M. Alexander Otto

Within 18 months of its launch, almost 2,000 people were enrolled in a new, international online registry for rare autoinflammatory diseases designed to facilitate research and treatment, as well as increase awareness of the conditions.

The registry, called Eurofever and launched in November 2009 with the support of the Executive Agency for Health and Consumers of the European Union (EAHC), includes demographic, clinical, and genetic information on people who have developed familial Mediterranean fever, tumor necrosis factor receptor–associated periodic syndrome (TRAPS), mevalonate kinase deficiency, Behçet’s disease, and other conditions, more than 10 in all. Enrollment is ongoing, and new autoinflammatory conditions will be added as they are recognized.

The Eurofever registry is "available for analysis on clinical presentation, disease course, and response to treatment, and to perform large-scale comparative studies between different conditions," according to its founders. It can be accessed in the member area of the Pediatric Rheumatology International Trial Organisation (PRINTO) website. Enrollment information is on the registry’s website.

The goal of the efforts is to counteract "a major limitation to understanding these rare conditions[,] the fragmentation of clinical experience with very few centers in any country caring for more than a handful of cases," according to principal investigator and pediatric rheumatologist Marco Gattorno of the University of Genoa (Italy) and his associates. The investigators solicited enrollment from pediatric and adult centers known to have an interest in rare autoinflammatory diseases (Ann. Rheum. Dis. 2012 Feb. 29 [doi: 10.1136/annrheumdis-2011-200549]).

So far, the registry includes 916 males and 964 females from 67 centers in 31 countries. Three-quarters are under 18 years of age, consistent with the fact that the conditions tend to present in childhood. Three-quarters also reside in Western Europe; 16% in Turkey, Israel, or North Africa; 6% in Eastern Europe, and the rest in Asia, South America, and Australia.

Although North America and many South American and Asian countries "are not yet covered by the registry, the large number of patients recruited in this first period of the project and the wide geographical distribution is very encouraging and suggests that the network can continue to grow," Dr. Gattorno and his colleagues noted.

The efforts are already paying off. An analysis of registry data resulted in identification of three previously unreported mutations for TRAPS, four for mevalonate kinase deficiency, and two for cryopyrin associated periodic syndromes.

The investigators found that physicians are making the diagnosis more quickly. Although the median delay between disease onset and diagnosis was 7.3 years, there is a "trend towards shorter diagnostic delay in patients born" in the current century – 1.4 years for familial Mediterranean fever, for instance – robably "due to the fact that many of these diseases are recently recognized clinical entities and that genetic diagnosis has ...become relatively widely available in the last few years," they noted.

Even so, "the marked bias towards Western Europe," where there are relatively large number of centers with facilities for genetic analysis, may suggest that recognition remains a problem elsewhere, they noted.*

The EAHC is funding the project, along with PRINTO, Novartis, and the Seventh Framework Programme (2007–2013) of the European Community for Research, Technological Development, and Demonstration Activities.

The authors said they had no relevant financial disclosures.

*CORRECTION: 03/12/2012 An earlier version of this story misstated the number of specialty centers with facilities for genetic analysis.

Within 18 months of its launch, almost 2,000 people were enrolled in a new, international online registry for rare autoinflammatory diseases designed to facilitate research and treatment, as well as increase awareness of the conditions.

The registry, called Eurofever and launched in November 2009 with the support of the Executive Agency for Health and Consumers of the European Union (EAHC), includes demographic, clinical, and genetic information on people who have developed familial Mediterranean fever, tumor necrosis factor receptor–associated periodic syndrome (TRAPS), mevalonate kinase deficiency, Behçet’s disease, and other conditions, more than 10 in all. Enrollment is ongoing, and new autoinflammatory conditions will be added as they are recognized.

The Eurofever registry is "available for analysis on clinical presentation, disease course, and response to treatment, and to perform large-scale comparative studies between different conditions," according to its founders. It can be accessed in the member area of the Pediatric Rheumatology International Trial Organisation (PRINTO) website. Enrollment information is on the registry’s website.

The goal of the efforts is to counteract "a major limitation to understanding these rare conditions[,] the fragmentation of clinical experience with very few centers in any country caring for more than a handful of cases," according to principal investigator and pediatric rheumatologist Marco Gattorno of the University of Genoa (Italy) and his associates. The investigators solicited enrollment from pediatric and adult centers known to have an interest in rare autoinflammatory diseases (Ann. Rheum. Dis. 2012 Feb. 29 [doi: 10.1136/annrheumdis-2011-200549]).

So far, the registry includes 916 males and 964 females from 67 centers in 31 countries. Three-quarters are under 18 years of age, consistent with the fact that the conditions tend to present in childhood. Three-quarters also reside in Western Europe; 16% in Turkey, Israel, or North Africa; 6% in Eastern Europe, and the rest in Asia, South America, and Australia.

Although North America and many South American and Asian countries "are not yet covered by the registry, the large number of patients recruited in this first period of the project and the wide geographical distribution is very encouraging and suggests that the network can continue to grow," Dr. Gattorno and his colleagues noted.

The efforts are already paying off. An analysis of registry data resulted in identification of three previously unreported mutations for TRAPS, four for mevalonate kinase deficiency, and two for cryopyrin associated periodic syndromes.

The investigators found that physicians are making the diagnosis more quickly. Although the median delay between disease onset and diagnosis was 7.3 years, there is a "trend towards shorter diagnostic delay in patients born" in the current century – 1.4 years for familial Mediterranean fever, for instance – robably "due to the fact that many of these diseases are recently recognized clinical entities and that genetic diagnosis has ...become relatively widely available in the last few years," they noted.

Even so, "the marked bias towards Western Europe," where there are relatively large number of centers with facilities for genetic analysis, may suggest that recognition remains a problem elsewhere, they noted.*

The EAHC is funding the project, along with PRINTO, Novartis, and the Seventh Framework Programme (2007–2013) of the European Community for Research, Technological Development, and Demonstration Activities.

The authors said they had no relevant financial disclosures.

*CORRECTION: 03/12/2012 An earlier version of this story misstated the number of specialty centers with facilities for genetic analysis.

Within 18 months of its launch, almost 2,000 people were enrolled in a new, international online registry for rare autoinflammatory diseases designed to facilitate research and treatment, as well as increase awareness of the conditions.

The registry, called Eurofever and launched in November 2009 with the support of the Executive Agency for Health and Consumers of the European Union (EAHC), includes demographic, clinical, and genetic information on people who have developed familial Mediterranean fever, tumor necrosis factor receptor–associated periodic syndrome (TRAPS), mevalonate kinase deficiency, Behçet’s disease, and other conditions, more than 10 in all. Enrollment is ongoing, and new autoinflammatory conditions will be added as they are recognized.

The Eurofever registry is "available for analysis on clinical presentation, disease course, and response to treatment, and to perform large-scale comparative studies between different conditions," according to its founders. It can be accessed in the member area of the Pediatric Rheumatology International Trial Organisation (PRINTO) website. Enrollment information is on the registry’s website.

The goal of the efforts is to counteract "a major limitation to understanding these rare conditions[,] the fragmentation of clinical experience with very few centers in any country caring for more than a handful of cases," according to principal investigator and pediatric rheumatologist Marco Gattorno of the University of Genoa (Italy) and his associates. The investigators solicited enrollment from pediatric and adult centers known to have an interest in rare autoinflammatory diseases (Ann. Rheum. Dis. 2012 Feb. 29 [doi: 10.1136/annrheumdis-2011-200549]).

So far, the registry includes 916 males and 964 females from 67 centers in 31 countries. Three-quarters are under 18 years of age, consistent with the fact that the conditions tend to present in childhood. Three-quarters also reside in Western Europe; 16% in Turkey, Israel, or North Africa; 6% in Eastern Europe, and the rest in Asia, South America, and Australia.

Although North America and many South American and Asian countries "are not yet covered by the registry, the large number of patients recruited in this first period of the project and the wide geographical distribution is very encouraging and suggests that the network can continue to grow," Dr. Gattorno and his colleagues noted.

The efforts are already paying off. An analysis of registry data resulted in identification of three previously unreported mutations for TRAPS, four for mevalonate kinase deficiency, and two for cryopyrin associated periodic syndromes.

The investigators found that physicians are making the diagnosis more quickly. Although the median delay between disease onset and diagnosis was 7.3 years, there is a "trend towards shorter diagnostic delay in patients born" in the current century – 1.4 years for familial Mediterranean fever, for instance – robably "due to the fact that many of these diseases are recently recognized clinical entities and that genetic diagnosis has ...become relatively widely available in the last few years," they noted.

Even so, "the marked bias towards Western Europe," where there are relatively large number of centers with facilities for genetic analysis, may suggest that recognition remains a problem elsewhere, they noted.*

The EAHC is funding the project, along with PRINTO, Novartis, and the Seventh Framework Programme (2007–2013) of the European Community for Research, Technological Development, and Demonstration Activities.

The authors said they had no relevant financial disclosures.

*CORRECTION: 03/12/2012 An earlier version of this story misstated the number of specialty centers with facilities for genetic analysis.

Valgus knee braces used in conjunction with specialized footwear reduced pain from medial tibiofemoral osteoarthritis by about 20% in a 30-week controlled trial, perhaps the most rigorous investigation of realignment treatment for knee osteoarthritis to date.

In a trial of randomized crossover design, 80 patients either wore a valgus knee brace (Oadjuster) plus customized neutral foot orthoses and motion-control shoes or a neutral knee brace (Montana) plus flat, nonsupportive foot orthoses and flexible mid-sole shoes for 12 weeks. They next went without treatment for 6 weeks, and then were crossed over to the alternative treatment for another 12 weeks.

Scores on the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain scale were a mean of 1.82 units (95% confidence interval, –3.05 to –0.60; P value less than .004) lower when patients wore the valgus brace instead of the neutral brace. Overall, use of the valgus brace and orthoses reduced their pain by 20% from its baseline level. WOMAC function scores were 2.90 units lower (95% CI, –6.60 to 0.79) as well, but the finding was not significant (P value .12).

"We have demonstrated that the application of realignment treatment ... leads to a statistically significant improvement in knee pain compared to a placebo intervention," concluded lead author and rheumatologist Dr. David Hunter, professor of medicine at the University of Sydney and his colleagues at the New England Baptist Hospital in Boston (Ann. Rheum. Dis. 2012 Feb. 29 [doi: 10.1136/annrheumdis-2011-200728]).

It’s not the first time valgus unloader braces have been shown to help medial knee osteoarthritis (OA). However, brace adherence and lack of adequate control treatments may have skewed findings from previous trials. There was a "need for an appropriately powered and well-controlled trial on the effect of valgus knee bracing on persons with medial knee OA. We were adequately powered to detect a clinically meaningful treatment effect," the researchers noted.

On average, patients wore their braces for more than 3 hours each day. Their mean age was 62 years, and mean body mass index 34 kg/m²; most were women. Patients were ambulatory without assistance but on most days had knee pain, aching, or stiffness. Their baseline pain score was 9.2 on the 20-point WOMAC scale. Radiographs confirmed osteophytes and predominantly medial tibiofemoral OA.

Patients in the trial were new to prescription knee braces and customized orthotics. To help control for the placebo effect – strong in OA trials – they weren’t told that the valgus brace was the active treatment.

Despite better pain control, however, the active treatment was more problematic. Sixteen patients had a hard time keeping the valgus brace in place, a problem for only four with the neutral brace. Seven patients said the motion-control shoes were painful. Just one said the flexible midsole control shoes hurt.

The researchers included the shoes and inserts because "even with appropriate valgus bracing, large mechanical stresses on the knee can persist, suggesting that the addition of other interventions to further improve limb alignment may be of therapeutic value," they noted.

In all, 24 patients (30%) dropped out of the study. Some were lost to follow-up, while others scheduled joint replacements or didn’t comply with treatment. An intent-to-treat analysis was used to reduce the impact.

DonJoy supplied the braces, and New Balance supplied the shoes and inserts. The companies otherwise were uninvolved in the project, which was funded by the National Institute on Disability and Rehabilitation Research. The researchers reported no relevant financial conflicts of interest.

Valgus knee braces used in conjunction with specialized footwear reduced pain from medial tibiofemoral osteoarthritis by about 20% in a 30-week controlled trial, perhaps the most rigorous investigation of realignment treatment for knee osteoarthritis to date.

In a trial of randomized crossover design, 80 patients either wore a valgus knee brace (Oadjuster) plus customized neutral foot orthoses and motion-control shoes or a neutral knee brace (Montana) plus flat, nonsupportive foot orthoses and flexible mid-sole shoes for 12 weeks. They next went without treatment for 6 weeks, and then were crossed over to the alternative treatment for another 12 weeks.

Scores on the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain scale were a mean of 1.82 units (95% confidence interval, –3.05 to –0.60; P value less than .004) lower when patients wore the valgus brace instead of the neutral brace. Overall, use of the valgus brace and orthoses reduced their pain by 20% from its baseline level. WOMAC function scores were 2.90 units lower (95% CI, –6.60 to 0.79) as well, but the finding was not significant (P value .12).

"We have demonstrated that the application of realignment treatment ... leads to a statistically significant improvement in knee pain compared to a placebo intervention," concluded lead author and rheumatologist Dr. David Hunter, professor of medicine at the University of Sydney and his colleagues at the New England Baptist Hospital in Boston (Ann. Rheum. Dis. 2012 Feb. 29 [doi: 10.1136/annrheumdis-2011-200728]).

It’s not the first time valgus unloader braces have been shown to help medial knee osteoarthritis (OA). However, brace adherence and lack of adequate control treatments may have skewed findings from previous trials. There was a "need for an appropriately powered and well-controlled trial on the effect of valgus knee bracing on persons with medial knee OA. We were adequately powered to detect a clinically meaningful treatment effect," the researchers noted.

On average, patients wore their braces for more than 3 hours each day. Their mean age was 62 years, and mean body mass index 34 kg/m²; most were women. Patients were ambulatory without assistance but on most days had knee pain, aching, or stiffness. Their baseline pain score was 9.2 on the 20-point WOMAC scale. Radiographs confirmed osteophytes and predominantly medial tibiofemoral OA.

Patients in the trial were new to prescription knee braces and customized orthotics. To help control for the placebo effect – strong in OA trials – they weren’t told that the valgus brace was the active treatment.

Despite better pain control, however, the active treatment was more problematic. Sixteen patients had a hard time keeping the valgus brace in place, a problem for only four with the neutral brace. Seven patients said the motion-control shoes were painful. Just one said the flexible midsole control shoes hurt.

The researchers included the shoes and inserts because "even with appropriate valgus bracing, large mechanical stresses on the knee can persist, suggesting that the addition of other interventions to further improve limb alignment may be of therapeutic value," they noted.

In all, 24 patients (30%) dropped out of the study. Some were lost to follow-up, while others scheduled joint replacements or didn’t comply with treatment. An intent-to-treat analysis was used to reduce the impact.

DonJoy supplied the braces, and New Balance supplied the shoes and inserts. The companies otherwise were uninvolved in the project, which was funded by the National Institute on Disability and Rehabilitation Research. The researchers reported no relevant financial conflicts of interest.

Valgus knee braces used in conjunction with specialized footwear reduced pain from medial tibiofemoral osteoarthritis by about 20% in a 30-week controlled trial, perhaps the most rigorous investigation of realignment treatment for knee osteoarthritis to date.

In a trial of randomized crossover design, 80 patients either wore a valgus knee brace (Oadjuster) plus customized neutral foot orthoses and motion-control shoes or a neutral knee brace (Montana) plus flat, nonsupportive foot orthoses and flexible mid-sole shoes for 12 weeks. They next went without treatment for 6 weeks, and then were crossed over to the alternative treatment for another 12 weeks.

Scores on the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain scale were a mean of 1.82 units (95% confidence interval, –3.05 to –0.60; P value less than .004) lower when patients wore the valgus brace instead of the neutral brace. Overall, use of the valgus brace and orthoses reduced their pain by 20% from its baseline level. WOMAC function scores were 2.90 units lower (95% CI, –6.60 to 0.79) as well, but the finding was not significant (P value .12).

"We have demonstrated that the application of realignment treatment ... leads to a statistically significant improvement in knee pain compared to a placebo intervention," concluded lead author and rheumatologist Dr. David Hunter, professor of medicine at the University of Sydney and his colleagues at the New England Baptist Hospital in Boston (Ann. Rheum. Dis. 2012 Feb. 29 [doi: 10.1136/annrheumdis-2011-200728]).

It’s not the first time valgus unloader braces have been shown to help medial knee osteoarthritis (OA). However, brace adherence and lack of adequate control treatments may have skewed findings from previous trials. There was a "need for an appropriately powered and well-controlled trial on the effect of valgus knee bracing on persons with medial knee OA. We were adequately powered to detect a clinically meaningful treatment effect," the researchers noted.

On average, patients wore their braces for more than 3 hours each day. Their mean age was 62 years, and mean body mass index 34 kg/m²; most were women. Patients were ambulatory without assistance but on most days had knee pain, aching, or stiffness. Their baseline pain score was 9.2 on the 20-point WOMAC scale. Radiographs confirmed osteophytes and predominantly medial tibiofemoral OA.

Patients in the trial were new to prescription knee braces and customized orthotics. To help control for the placebo effect – strong in OA trials – they weren’t told that the valgus brace was the active treatment.

Despite better pain control, however, the active treatment was more problematic. Sixteen patients had a hard time keeping the valgus brace in place, a problem for only four with the neutral brace. Seven patients said the motion-control shoes were painful. Just one said the flexible midsole control shoes hurt.

The researchers included the shoes and inserts because "even with appropriate valgus bracing, large mechanical stresses on the knee can persist, suggesting that the addition of other interventions to further improve limb alignment may be of therapeutic value," they noted.

In all, 24 patients (30%) dropped out of the study. Some were lost to follow-up, while others scheduled joint replacements or didn’t comply with treatment. An intent-to-treat analysis was used to reduce the impact.

DonJoy supplied the braces, and New Balance supplied the shoes and inserts. The companies otherwise were uninvolved in the project, which was funded by the National Institute on Disability and Rehabilitation Research. The researchers reported no relevant financial conflicts of interest.

PHOENIX – It’s a good idea to remind insomnia patients not to mix benzodiazepine receptor agonists – zaleplon, zolpidem, and eszopiclone – with antihistamines, antinausea drugs such as promethazine, or alcohol.

Mixing the so-called Z-drugs with those or other sedating agents can trigger sleepwalking, sleep driving, or sleep eating, among other problems, in approximately 1 in 1,000 people. Those affected might "get up in the morning and find the kitchen is a mess and all the food is pulled out of the refrigerator. They’ll have no memory of it," said Dr. James Parish, medical director of the center for sleep medicine at the Mayo Clinic in Scottsdale, Ariz.

When Dr. Parish prescribes a Z-drug, "I warn people about this effect and [that] if this happens, they should stop [the drug] immediately and not use it again," he said.

Otherwise, the Z-drugs have a good safety profile. Sublingual zolpidem (Intermezzo), the most recent entry in the class, has a 2.5-hour half-life and can be used for middle-of-the-night insomnia if patients have at least 4 hours left in bed. Zaleplon (Sonata) has a 1-hour half-life and can also be used in the middle of night, Dr. Parish said at a meeting on sleep medicine sponsored by the American College of Chest Physicians.

The Z-drugs, along with short- to intermediate-acting benzodiazepines and ramelteon (Rozerem), are first-line options for insomnia, according to American Academy of Sleep Medicine guidelines (J. Clin. Sleep Med. 2008;4:487-504).

Benzodiazepines with longer half-lives and active metabolites should be avoided for insomnia, Dr. Parish said. These agents can cause daytime sleepiness and cognitive impairment, among other problems, especially in elderly people less able to metabolize them.

After months or years of long-acting benzodiazepine use, rebound insomnia is an issue, as well. Patients stop the medication and "boom, their sleep is worse than ever for a week or two" before normalizing. The problem can keep "patients taking these drugs for years and years," Dr. Parish said.

So it’s important to let patients know beforehand about the rebound potential, and tell them "that it’s going to be bad for a while, but don’t panic. Things will [get] better," he said.

Ramelteon, a melatonin receptor agonist, "is another useful drug." With no affinity for benzodiazepine receptors, it should not cause daytime drowsiness, he said.

Ramelteon metabolizes in the liver, so it can’t be used in patients with liver disease. It also increases concentrations of alcohol, azole antifungal drugs, and fluvoxamine, and decreases rifampin levels.

"You have to think about how it’s going to affect other drugs. Given that, I think it’s a reasonably effective, reasonably safe drug," Dr. Parish said.

Because they have anticholinergic and antihistaminic effects, some antidepressants are insomnia options, too, but not as first-line agents and at doses lower than those used for depression.

The tricyclic antidepressant doxepin (Silenor) was approved for insomnia in 2010 at 3-mg and 6-mg doses, but it cannot be used with monoamine oxidase inhibitors.

Follow-up is important with all insomnia agents to assess effect and safety and to monitor for dose escalation. Concomitant cognitive-behavioral therapies – stimulus control and sleep restriction, for example – are helpful as well, with the goal of tapering patients off sleeping pills as behavior therapy takes effect.

Dr. Parish said he had no relevant financial disclosures.

PHOENIX – It’s a good idea to remind insomnia patients not to mix benzodiazepine receptor agonists – zaleplon, zolpidem, and eszopiclone – with antihistamines, antinausea drugs such as promethazine, or alcohol.

Mixing the so-called Z-drugs with those or other sedating agents can trigger sleepwalking, sleep driving, or sleep eating, among other problems, in approximately 1 in 1,000 people. Those affected might "get up in the morning and find the kitchen is a mess and all the food is pulled out of the refrigerator. They’ll have no memory of it," said Dr. James Parish, medical director of the center for sleep medicine at the Mayo Clinic in Scottsdale, Ariz.

When Dr. Parish prescribes a Z-drug, "I warn people about this effect and [that] if this happens, they should stop [the drug] immediately and not use it again," he said.

Otherwise, the Z-drugs have a good safety profile. Sublingual zolpidem (Intermezzo), the most recent entry in the class, has a 2.5-hour half-life and can be used for middle-of-the-night insomnia if patients have at least 4 hours left in bed. Zaleplon (Sonata) has a 1-hour half-life and can also be used in the middle of night, Dr. Parish said at a meeting on sleep medicine sponsored by the American College of Chest Physicians.

The Z-drugs, along with short- to intermediate-acting benzodiazepines and ramelteon (Rozerem), are first-line options for insomnia, according to American Academy of Sleep Medicine guidelines (J. Clin. Sleep Med. 2008;4:487-504).

Benzodiazepines with longer half-lives and active metabolites should be avoided for insomnia, Dr. Parish said. These agents can cause daytime sleepiness and cognitive impairment, among other problems, especially in elderly people less able to metabolize them.

After months or years of long-acting benzodiazepine use, rebound insomnia is an issue, as well. Patients stop the medication and "boom, their sleep is worse than ever for a week or two" before normalizing. The problem can keep "patients taking these drugs for years and years," Dr. Parish said.

So it’s important to let patients know beforehand about the rebound potential, and tell them "that it’s going to be bad for a while, but don’t panic. Things will [get] better," he said.

Ramelteon, a melatonin receptor agonist, "is another useful drug." With no affinity for benzodiazepine receptors, it should not cause daytime drowsiness, he said.

Ramelteon metabolizes in the liver, so it can’t be used in patients with liver disease. It also increases concentrations of alcohol, azole antifungal drugs, and fluvoxamine, and decreases rifampin levels.

"You have to think about how it’s going to affect other drugs. Given that, I think it’s a reasonably effective, reasonably safe drug," Dr. Parish said.

Because they have anticholinergic and antihistaminic effects, some antidepressants are insomnia options, too, but not as first-line agents and at doses lower than those used for depression.

The tricyclic antidepressant doxepin (Silenor) was approved for insomnia in 2010 at 3-mg and 6-mg doses, but it cannot be used with monoamine oxidase inhibitors.

Follow-up is important with all insomnia agents to assess effect and safety and to monitor for dose escalation. Concomitant cognitive-behavioral therapies – stimulus control and sleep restriction, for example – are helpful as well, with the goal of tapering patients off sleeping pills as behavior therapy takes effect.

Dr. Parish said he had no relevant financial disclosures.

PHOENIX – It’s a good idea to remind insomnia patients not to mix benzodiazepine receptor agonists – zaleplon, zolpidem, and eszopiclone – with antihistamines, antinausea drugs such as promethazine, or alcohol.

Mixing the so-called Z-drugs with those or other sedating agents can trigger sleepwalking, sleep driving, or sleep eating, among other problems, in approximately 1 in 1,000 people. Those affected might "get up in the morning and find the kitchen is a mess and all the food is pulled out of the refrigerator. They’ll have no memory of it," said Dr. James Parish, medical director of the center for sleep medicine at the Mayo Clinic in Scottsdale, Ariz.

When Dr. Parish prescribes a Z-drug, "I warn people about this effect and [that] if this happens, they should stop [the drug] immediately and not use it again," he said.

Otherwise, the Z-drugs have a good safety profile. Sublingual zolpidem (Intermezzo), the most recent entry in the class, has a 2.5-hour half-life and can be used for middle-of-the-night insomnia if patients have at least 4 hours left in bed. Zaleplon (Sonata) has a 1-hour half-life and can also be used in the middle of night, Dr. Parish said at a meeting on sleep medicine sponsored by the American College of Chest Physicians.

The Z-drugs, along with short- to intermediate-acting benzodiazepines and ramelteon (Rozerem), are first-line options for insomnia, according to American Academy of Sleep Medicine guidelines (J. Clin. Sleep Med. 2008;4:487-504).

Benzodiazepines with longer half-lives and active metabolites should be avoided for insomnia, Dr. Parish said. These agents can cause daytime sleepiness and cognitive impairment, among other problems, especially in elderly people less able to metabolize them.

After months or years of long-acting benzodiazepine use, rebound insomnia is an issue, as well. Patients stop the medication and "boom, their sleep is worse than ever for a week or two" before normalizing. The problem can keep "patients taking these drugs for years and years," Dr. Parish said.

So it’s important to let patients know beforehand about the rebound potential, and tell them "that it’s going to be bad for a while, but don’t panic. Things will [get] better," he said.

Ramelteon, a melatonin receptor agonist, "is another useful drug." With no affinity for benzodiazepine receptors, it should not cause daytime drowsiness, he said.

Ramelteon metabolizes in the liver, so it can’t be used in patients with liver disease. It also increases concentrations of alcohol, azole antifungal drugs, and fluvoxamine, and decreases rifampin levels.

"You have to think about how it’s going to affect other drugs. Given that, I think it’s a reasonably effective, reasonably safe drug," Dr. Parish said.

Because they have anticholinergic and antihistaminic effects, some antidepressants are insomnia options, too, but not as first-line agents and at doses lower than those used for depression.

The tricyclic antidepressant doxepin (Silenor) was approved for insomnia in 2010 at 3-mg and 6-mg doses, but it cannot be used with monoamine oxidase inhibitors.

Follow-up is important with all insomnia agents to assess effect and safety and to monitor for dose escalation. Concomitant cognitive-behavioral therapies – stimulus control and sleep restriction, for example – are helpful as well, with the goal of tapering patients off sleeping pills as behavior therapy takes effect.

Dr. Parish said he had no relevant financial disclosures.

PHOENIX – For uncomplicated, moderate to severe obstructive sleep apnea, autoadjusting positive airway pressure is as effective as continuous positive airway pressure titrated in a sleep laboratory, according to Dr. Neil Freedman, a sleep medicine specialist and pulmonologist in Bannockburn, Ill.

Randomized controlled trials comparing lab-titrated continuous positive airway pressure (CPAP) to autoadjusting positive airway pressure (APAP) in unattended settings have shown similar compliance, apnea-hypopnea index (AHI), and daytime sleepiness improvements (Sleep 2010;33:267-71).

That raises the possibility of sending uncomplicated obstructive sleep apnea patients home with APAP machines to see how they do, instead of to a sleep lab. With insurance companies, among others, interested in that option, "in the near future patients who need CPAP – if they have uncomplicated sleep apnea – are going to get an unattended APAP trial whether they’re going to be treated long-term with it or they are going to be pushed to CPAP. It’s not inappropriate, as long as you know what you’re doing," Dr. Freedman said at a meeting on sleep medicine sponsored by the American College of Chest Physicians.

APAP machines don’t provide continuous pressure, but instead detect and respond to changes in upper airway flow or resistance patterns; the idea is to use the minimal effective pressure needed to maintain airway patency, which can change for various reasons, even body position.

Initially, machines are typically set to a minimum pressure of 4 cm H₂O and a maximum pressure of 20 cm H₂O. Dr. Freedman starts on the higher side with obese patients and those with worse symptoms, and also includes heated humidification and a gradual ramp-up to therapeutic pressures at the start of sleep.

"The overwhelming majority" of patients are going to need pressure of 8 to 12 cm H₂O. If patients need more than 14 cm H₂O, "there’s probably something else going on," he said.

Despite APAP’s effectiveness, that there are several unresolved issues, he cautioned.

First, the machines use different technologies and algorithms to treat events, so data from one APAP study is specific to the device used in that trial, and cannot be generalized to other machines. It’s important for clinicians to know their device and its weaknesses, but "provider knowledge, patient education, and early follow-up are more important than the type of device used." If patients still complain about snoring, being sleepy during the day, or other issues despite treatment, "look for problems. When in doubt, send them back to the lab," Dr. Freedman said.

Some machines can have trouble distinguishing true obstructive apneic events and central sleep apnea – apneic episodes despite an open airway – and misestimate the apnea-hypopnea index.

Patients may come in with a high AHI and events marked that "should be obstructive events" but that didn’t get better with increased pressure, which suggests central apnea. "If you inappropriately increase the pressure, you may actually make things worse for the patient," he noted. Excessive mask leaking can artificially inflate the AHI as well, so it’s important to use the mask or breathing apparatus recommended for a given machine. A proper fit also helps ensure the machines accurately capture snoring data, a measure of mask vibration, Dr. Freedman said.

Most APAP machines are flow based, which means they rely on the absence of flow back at the machine to detect events. A different approach, the forced oscillation technique (FOT), also is available to differentiate obstructive events from central apneic events. FOT reads changes in patterns of resistance; an absence of flow, despite low resistance, likely indicates a central event.

Dr. Freedman said he had no relevant disclosures.

PHOENIX – For uncomplicated, moderate to severe obstructive sleep apnea, autoadjusting positive airway pressure is as effective as continuous positive airway pressure titrated in a sleep laboratory, according to Dr. Neil Freedman, a sleep medicine specialist and pulmonologist in Bannockburn, Ill.

Randomized controlled trials comparing lab-titrated continuous positive airway pressure (CPAP) to autoadjusting positive airway pressure (APAP) in unattended settings have shown similar compliance, apnea-hypopnea index (AHI), and daytime sleepiness improvements (Sleep 2010;33:267-71).

That raises the possibility of sending uncomplicated obstructive sleep apnea patients home with APAP machines to see how they do, instead of to a sleep lab. With insurance companies, among others, interested in that option, "in the near future patients who need CPAP – if they have uncomplicated sleep apnea – are going to get an unattended APAP trial whether they’re going to be treated long-term with it or they are going to be pushed to CPAP. It’s not inappropriate, as long as you know what you’re doing," Dr. Freedman said at a meeting on sleep medicine sponsored by the American College of Chest Physicians.

APAP machines don’t provide continuous pressure, but instead detect and respond to changes in upper airway flow or resistance patterns; the idea is to use the minimal effective pressure needed to maintain airway patency, which can change for various reasons, even body position.

Initially, machines are typically set to a minimum pressure of 4 cm H₂O and a maximum pressure of 20 cm H₂O. Dr. Freedman starts on the higher side with obese patients and those with worse symptoms, and also includes heated humidification and a gradual ramp-up to therapeutic pressures at the start of sleep.

"The overwhelming majority" of patients are going to need pressure of 8 to 12 cm H₂O. If patients need more than 14 cm H₂O, "there’s probably something else going on," he said.

Despite APAP’s effectiveness, that there are several unresolved issues, he cautioned.

First, the machines use different technologies and algorithms to treat events, so data from one APAP study is specific to the device used in that trial, and cannot be generalized to other machines. It’s important for clinicians to know their device and its weaknesses, but "provider knowledge, patient education, and early follow-up are more important than the type of device used." If patients still complain about snoring, being sleepy during the day, or other issues despite treatment, "look for problems. When in doubt, send them back to the lab," Dr. Freedman said.

Some machines can have trouble distinguishing true obstructive apneic events and central sleep apnea – apneic episodes despite an open airway – and misestimate the apnea-hypopnea index.

Patients may come in with a high AHI and events marked that "should be obstructive events" but that didn’t get better with increased pressure, which suggests central apnea. "If you inappropriately increase the pressure, you may actually make things worse for the patient," he noted. Excessive mask leaking can artificially inflate the AHI as well, so it’s important to use the mask or breathing apparatus recommended for a given machine. A proper fit also helps ensure the machines accurately capture snoring data, a measure of mask vibration, Dr. Freedman said.

Most APAP machines are flow based, which means they rely on the absence of flow back at the machine to detect events. A different approach, the forced oscillation technique (FOT), also is available to differentiate obstructive events from central apneic events. FOT reads changes in patterns of resistance; an absence of flow, despite low resistance, likely indicates a central event.

Dr. Freedman said he had no relevant disclosures.

PHOENIX – For uncomplicated, moderate to severe obstructive sleep apnea, autoadjusting positive airway pressure is as effective as continuous positive airway pressure titrated in a sleep laboratory, according to Dr. Neil Freedman, a sleep medicine specialist and pulmonologist in Bannockburn, Ill.

Randomized controlled trials comparing lab-titrated continuous positive airway pressure (CPAP) to autoadjusting positive airway pressure (APAP) in unattended settings have shown similar compliance, apnea-hypopnea index (AHI), and daytime sleepiness improvements (Sleep 2010;33:267-71).

That raises the possibility of sending uncomplicated obstructive sleep apnea patients home with APAP machines to see how they do, instead of to a sleep lab. With insurance companies, among others, interested in that option, "in the near future patients who need CPAP – if they have uncomplicated sleep apnea – are going to get an unattended APAP trial whether they’re going to be treated long-term with it or they are going to be pushed to CPAP. It’s not inappropriate, as long as you know what you’re doing," Dr. Freedman said at a meeting on sleep medicine sponsored by the American College of Chest Physicians.

APAP machines don’t provide continuous pressure, but instead detect and respond to changes in upper airway flow or resistance patterns; the idea is to use the minimal effective pressure needed to maintain airway patency, which can change for various reasons, even body position.

Initially, machines are typically set to a minimum pressure of 4 cm H₂O and a maximum pressure of 20 cm H₂O. Dr. Freedman starts on the higher side with obese patients and those with worse symptoms, and also includes heated humidification and a gradual ramp-up to therapeutic pressures at the start of sleep.

"The overwhelming majority" of patients are going to need pressure of 8 to 12 cm H₂O. If patients need more than 14 cm H₂O, "there’s probably something else going on," he said.

Despite APAP’s effectiveness, that there are several unresolved issues, he cautioned.

First, the machines use different technologies and algorithms to treat events, so data from one APAP study is specific to the device used in that trial, and cannot be generalized to other machines. It’s important for clinicians to know their device and its weaknesses, but "provider knowledge, patient education, and early follow-up are more important than the type of device used." If patients still complain about snoring, being sleepy during the day, or other issues despite treatment, "look for problems. When in doubt, send them back to the lab," Dr. Freedman said.

Some machines can have trouble distinguishing true obstructive apneic events and central sleep apnea – apneic episodes despite an open airway – and misestimate the apnea-hypopnea index.

Patients may come in with a high AHI and events marked that "should be obstructive events" but that didn’t get better with increased pressure, which suggests central apnea. "If you inappropriately increase the pressure, you may actually make things worse for the patient," he noted. Excessive mask leaking can artificially inflate the AHI as well, so it’s important to use the mask or breathing apparatus recommended for a given machine. A proper fit also helps ensure the machines accurately capture snoring data, a measure of mask vibration, Dr. Freedman said.

Most APAP machines are flow based, which means they rely on the absence of flow back at the machine to detect events. A different approach, the forced oscillation technique (FOT), also is available to differentiate obstructive events from central apneic events. FOT reads changes in patterns of resistance; an absence of flow, despite low resistance, likely indicates a central event.

Dr. Freedman said he had no relevant disclosures.

PHOENIX – Sometimes, treating restless legs syndrome with dopaminergic agents can make the problem worse.

After months of use, patients might report that they still have symptoms in their calves, and now also in their thighs and arms, and not just at bedtime.

"It’s pretty dreadful when you see it. It happens as soon as they sit down in the evening. It might be much more intense than before," said Dr. Barbara A. Phillips a professor of medicine at the University of Kentucky, Lexington, and medical director of the school’s sleep disorders center.

The phenomena, known as augmentation, probably occurs in "something like 80%" of RLS patients treated with carbidopa-levodopa (Sinemet) nightly, and maybe up to 20% treated with pramipexole (Mirapex) and ropinirole (Requip), she said.

"The bad news is that it’s pretty common. The good news is there’s never been a case report that it didn’t go away when the drug was stopped," said Dr. Phillips, who is also the current president of the Sleep Institute of the American College of Chest Physicians.

Studies on how to manage augmentation are lacking, "but if [patients] are on Sinemet, stop it, and don’t ever use it again. If they’re on pramipexole, you could try switching them to ropinirole. If augmentation happens earlier in the day, you could split the dose and give them an earlier dose. Your strategy really has to be tailored to how the augmentation presents," she said at a meeting on sleep medicine sponsored by the American College of Chest Physicians.

Following its recent Food and Drug Administration approval for RLS, patients could also be switched to extended-release gabapentin (Horizant), an anticonvulsant, not a dopamine agonist, "but I can’t point to any science" supporting the move; "What I’m telling you here is opinion," Dr. Phillips said.

Compulsive behaviors – overeating, hair eating, gambling, and spree shopping, for instance – can also be a problem with dopaminergic agents at RLS doses. "If you’re going to use these agents, patients need to be asked ... and warned about such behaviors," she said.

Ropinirole and pramipexole must be titrated to effect; nausea is usually the limiting factor. Dr. Phillips and her colleagues typically start ropinirole patients on 0.5 mg and then titrate up every 3-6 days. In clinical trials, the average dosage was about 2 mg/day. "Sometimes, patients don’t think it’s helping, but often that’s because they’re still on 0.5 mg, which is probably not enough, or they are taking it right at bedtime," instead of 1-2 hours before bed, as required with dopaminergic RLS treatment.

Pramipexole is more potent, "so start at 0.125 mg and titrate up every 3-5 days," Dr. Phillips said. The average dosage in therapeutic trials was 0.25 mg/day, she added.

Ropinirole is hepatically metabolized and might be a good choice for people with renal failure. Pramipexole is renally excreted and might be the way to go for liver failure patients or those on other drugs metabolized by the liver.

Unlike ropinirole and pramipexole, levodopa does not carry an FDA indication for RLS, but is, nonetheless, effective. It can also cause nausea, but doesn’t have to be titrated and can be used as needed, making it a good option for people with infrequent attacks.

"Some people can predict they are going to have RLS if they are going to go out to dinner, have a glass of wine, sit in a small chair in the front row of the opera, and stay up late. But that’s only going to happen four times a year. They may not want to take a drug that has to be titrated and taken every night in order to deal with" an intermittent problem, she said.

Extended-release gabapentin is not associated with compulsive behaviors, but it’s expensive and likely associated with drowsiness at the 600-mg daily RLS dose. "And remember, all anticonvulsants carry various suicide warnings," Dr. Phillips said.

Dr. Phillips disclosed that she has been a speaker or consultant for groups funded by Cephalon, ResMed, and Respironics.

PHOENIX – Sometimes, treating restless legs syndrome with dopaminergic agents can make the problem worse.

After months of use, patients might report that they still have symptoms in their calves, and now also in their thighs and arms, and not just at bedtime.

"It’s pretty dreadful when you see it. It happens as soon as they sit down in the evening. It might be much more intense than before," said Dr. Barbara A. Phillips a professor of medicine at the University of Kentucky, Lexington, and medical director of the school’s sleep disorders center.

The phenomena, known as augmentation, probably occurs in "something like 80%" of RLS patients treated with carbidopa-levodopa (Sinemet) nightly, and maybe up to 20% treated with pramipexole (Mirapex) and ropinirole (Requip), she said.

"The bad news is that it’s pretty common. The good news is there’s never been a case report that it didn’t go away when the drug was stopped," said Dr. Phillips, who is also the current president of the Sleep Institute of the American College of Chest Physicians.

Studies on how to manage augmentation are lacking, "but if [patients] are on Sinemet, stop it, and don’t ever use it again. If they’re on pramipexole, you could try switching them to ropinirole. If augmentation happens earlier in the day, you could split the dose and give them an earlier dose. Your strategy really has to be tailored to how the augmentation presents," she said at a meeting on sleep medicine sponsored by the American College of Chest Physicians.

Following its recent Food and Drug Administration approval for RLS, patients could also be switched to extended-release gabapentin (Horizant), an anticonvulsant, not a dopamine agonist, "but I can’t point to any science" supporting the move; "What I’m telling you here is opinion," Dr. Phillips said.

Compulsive behaviors – overeating, hair eating, gambling, and spree shopping, for instance – can also be a problem with dopaminergic agents at RLS doses. "If you’re going to use these agents, patients need to be asked ... and warned about such behaviors," she said.

Ropinirole and pramipexole must be titrated to effect; nausea is usually the limiting factor. Dr. Phillips and her colleagues typically start ropinirole patients on 0.5 mg and then titrate up every 3-6 days. In clinical trials, the average dosage was about 2 mg/day. "Sometimes, patients don’t think it’s helping, but often that’s because they’re still on 0.5 mg, which is probably not enough, or they are taking it right at bedtime," instead of 1-2 hours before bed, as required with dopaminergic RLS treatment.

Pramipexole is more potent, "so start at 0.125 mg and titrate up every 3-5 days," Dr. Phillips said. The average dosage in therapeutic trials was 0.25 mg/day, she added.

Ropinirole is hepatically metabolized and might be a good choice for people with renal failure. Pramipexole is renally excreted and might be the way to go for liver failure patients or those on other drugs metabolized by the liver.

Unlike ropinirole and pramipexole, levodopa does not carry an FDA indication for RLS, but is, nonetheless, effective. It can also cause nausea, but doesn’t have to be titrated and can be used as needed, making it a good option for people with infrequent attacks.

"Some people can predict they are going to have RLS if they are going to go out to dinner, have a glass of wine, sit in a small chair in the front row of the opera, and stay up late. But that’s only going to happen four times a year. They may not want to take a drug that has to be titrated and taken every night in order to deal with" an intermittent problem, she said.

Extended-release gabapentin is not associated with compulsive behaviors, but it’s expensive and likely associated with drowsiness at the 600-mg daily RLS dose. "And remember, all anticonvulsants carry various suicide warnings," Dr. Phillips said.

Dr. Phillips disclosed that she has been a speaker or consultant for groups funded by Cephalon, ResMed, and Respironics.

PHOENIX – Sometimes, treating restless legs syndrome with dopaminergic agents can make the problem worse.

After months of use, patients might report that they still have symptoms in their calves, and now also in their thighs and arms, and not just at bedtime.

"It’s pretty dreadful when you see it. It happens as soon as they sit down in the evening. It might be much more intense than before," said Dr. Barbara A. Phillips a professor of medicine at the University of Kentucky, Lexington, and medical director of the school’s sleep disorders center.

The phenomena, known as augmentation, probably occurs in "something like 80%" of RLS patients treated with carbidopa-levodopa (Sinemet) nightly, and maybe up to 20% treated with pramipexole (Mirapex) and ropinirole (Requip), she said.

"The bad news is that it’s pretty common. The good news is there’s never been a case report that it didn’t go away when the drug was stopped," said Dr. Phillips, who is also the current president of the Sleep Institute of the American College of Chest Physicians.

Studies on how to manage augmentation are lacking, "but if [patients] are on Sinemet, stop it, and don’t ever use it again. If they’re on pramipexole, you could try switching them to ropinirole. If augmentation happens earlier in the day, you could split the dose and give them an earlier dose. Your strategy really has to be tailored to how the augmentation presents," she said at a meeting on sleep medicine sponsored by the American College of Chest Physicians.

Following its recent Food and Drug Administration approval for RLS, patients could also be switched to extended-release gabapentin (Horizant), an anticonvulsant, not a dopamine agonist, "but I can’t point to any science" supporting the move; "What I’m telling you here is opinion," Dr. Phillips said.

Compulsive behaviors – overeating, hair eating, gambling, and spree shopping, for instance – can also be a problem with dopaminergic agents at RLS doses. "If you’re going to use these agents, patients need to be asked ... and warned about such behaviors," she said.

Ropinirole and pramipexole must be titrated to effect; nausea is usually the limiting factor. Dr. Phillips and her colleagues typically start ropinirole patients on 0.5 mg and then titrate up every 3-6 days. In clinical trials, the average dosage was about 2 mg/day. "Sometimes, patients don’t think it’s helping, but often that’s because they’re still on 0.5 mg, which is probably not enough, or they are taking it right at bedtime," instead of 1-2 hours before bed, as required with dopaminergic RLS treatment.

Pramipexole is more potent, "so start at 0.125 mg and titrate up every 3-5 days," Dr. Phillips said. The average dosage in therapeutic trials was 0.25 mg/day, she added.

Ropinirole is hepatically metabolized and might be a good choice for people with renal failure. Pramipexole is renally excreted and might be the way to go for liver failure patients or those on other drugs metabolized by the liver.

Unlike ropinirole and pramipexole, levodopa does not carry an FDA indication for RLS, but is, nonetheless, effective. It can also cause nausea, but doesn’t have to be titrated and can be used as needed, making it a good option for people with infrequent attacks.

"Some people can predict they are going to have RLS if they are going to go out to dinner, have a glass of wine, sit in a small chair in the front row of the opera, and stay up late. But that’s only going to happen four times a year. They may not want to take a drug that has to be titrated and taken every night in order to deal with" an intermittent problem, she said.

Extended-release gabapentin is not associated with compulsive behaviors, but it’s expensive and likely associated with drowsiness at the 600-mg daily RLS dose. "And remember, all anticonvulsants carry various suicide warnings," Dr. Phillips said.

Dr. Phillips disclosed that she has been a speaker or consultant for groups funded by Cephalon, ResMed, and Respironics.

PHOENIX – Sleep medicine doctors need to get ahead of the curve on home sleep apnea testing or risk being put out of business, according to Dr. Charles W. Atwood Jr., director of the Sleep Disorders Program at the Veterans Affairs Pittsburgh Healthcare System.

Those "who can integrate this are going to survive, and [those] who can’t integrate this are not going to do as well," said Dr. Atwood, who is also an associate professor of medicine at the University of Pittsburgh.

Home sleep apnea testing (HSAT) is gaining traction among U.S. insurers because, among other things, it costs a lot less than traditional sleep lab apnea screening. Physician reimbursement is generally in the range of $180, compared with $700 or so for polysomnography. The Centers for Medicare and Medicaid Services are on board, as well, and have begun reimbursing for HSAT.

HSAT patients hook themselves up before bed to one of several HSAT devices on the market. The monitors typically measure airflow, respiratory effort, and heart rate, and include pulse oximetry. Results are later interpreted in the doctor’s office.

HSAT has only about 10% of the U.S. sleep study market at the moment, "quite small despite all the attention it gets," but with a lower price tag and studies showing that it is a viable alternative to polysomnography, the market is "likely to continue to increase. Most private [insurance] companies are going to want you do to this," Dr. Atwood said at a meeting on sleep medicine sponsored by the American College of Chest Physicians.

Sleep medicine physicians "need to think about companies that want to contract with primary care providers or insurance companies and get an exclusive contract that bars you from doing this kind of work. That has happened in certain markets, and it’s really devastated traditional sleep labs," he said.

Forestalling that means "getting to your insurance companies first and saying, ‘Look, we know this is coming. This is something that we can do. You’ll be happy with our services. Let’s talk,’ " Dr. Atwood said.

In the meantime, "network with your primary care and other referrers to make sure that they know you are doing this. They will want to know who’s going to take care of these patients if they can’t get a traditional sleep study," he said.

Overall, home sleep apnea testing "is not that hard," said Dr. Atwood, who researches HSAT and is a consultant for companies that make the devices.

Pick one system and get to know it well, and start with the easiest, least-complicated patients. Give some thought to who is going to teach patients how to use the devices – how-to videos are available for many – and how to get the devices back after patients are done with them. FedEx and UPS are options.

"You’ll also need to think about what to do with negative studies," he noted. You could take them at face value, repeat the test, or send patients to sleep labs for follow-up.

Home tests won’t work in about 10%-15% of patients, mostly because they will be noncompliant or will slip the pulse oximeter off while asleep. Also, because home testing generates fewer signals than does polysomnography, "you have to get comfortable making decisions with less information," Dr. Atwood said.

Nonetheless, he and his colleagues found that HSAT patients had no worse 3-month functional outcomes and continuous positive airway pressure (CPAP) adherence than did patients whose sleep apnea was diagnosed in a lab (Am. J. Respir. Crit. Care Med. 2011;183:1238-44).

Dr. Atwood receives commercial research support from Philips Respironics, Resmed, Embla, and Vapotherm. He is a consultant to Carecore, Resmed, and Philips Respironics.

PHOENIX – Sleep medicine doctors need to get ahead of the curve on home sleep apnea testing or risk being put out of business, according to Dr. Charles W. Atwood Jr., director of the Sleep Disorders Program at the Veterans Affairs Pittsburgh Healthcare System.

Those "who can integrate this are going to survive, and [those] who can’t integrate this are not going to do as well," said Dr. Atwood, who is also an associate professor of medicine at the University of Pittsburgh.

Home sleep apnea testing (HSAT) is gaining traction among U.S. insurers because, among other things, it costs a lot less than traditional sleep lab apnea screening. Physician reimbursement is generally in the range of $180, compared with $700 or so for polysomnography. The Centers for Medicare and Medicaid Services are on board, as well, and have begun reimbursing for HSAT.

HSAT patients hook themselves up before bed to one of several HSAT devices on the market. The monitors typically measure airflow, respiratory effort, and heart rate, and include pulse oximetry. Results are later interpreted in the doctor’s office.

HSAT has only about 10% of the U.S. sleep study market at the moment, "quite small despite all the attention it gets," but with a lower price tag and studies showing that it is a viable alternative to polysomnography, the market is "likely to continue to increase. Most private [insurance] companies are going to want you do to this," Dr. Atwood said at a meeting on sleep medicine sponsored by the American College of Chest Physicians.

Sleep medicine physicians "need to think about companies that want to contract with primary care providers or insurance companies and get an exclusive contract that bars you from doing this kind of work. That has happened in certain markets, and it’s really devastated traditional sleep labs," he said.

Forestalling that means "getting to your insurance companies first and saying, ‘Look, we know this is coming. This is something that we can do. You’ll be happy with our services. Let’s talk,’ " Dr. Atwood said.

In the meantime, "network with your primary care and other referrers to make sure that they know you are doing this. They will want to know who’s going to take care of these patients if they can’t get a traditional sleep study," he said.

Overall, home sleep apnea testing "is not that hard," said Dr. Atwood, who researches HSAT and is a consultant for companies that make the devices.

Pick one system and get to know it well, and start with the easiest, least-complicated patients. Give some thought to who is going to teach patients how to use the devices – how-to videos are available for many – and how to get the devices back after patients are done with them. FedEx and UPS are options.

"You’ll also need to think about what to do with negative studies," he noted. You could take them at face value, repeat the test, or send patients to sleep labs for follow-up.

Home tests won’t work in about 10%-15% of patients, mostly because they will be noncompliant or will slip the pulse oximeter off while asleep. Also, because home testing generates fewer signals than does polysomnography, "you have to get comfortable making decisions with less information," Dr. Atwood said.

Nonetheless, he and his colleagues found that HSAT patients had no worse 3-month functional outcomes and continuous positive airway pressure (CPAP) adherence than did patients whose sleep apnea was diagnosed in a lab (Am. J. Respir. Crit. Care Med. 2011;183:1238-44).

Dr. Atwood receives commercial research support from Philips Respironics, Resmed, Embla, and Vapotherm. He is a consultant to Carecore, Resmed, and Philips Respironics.

PHOENIX – Sleep medicine doctors need to get ahead of the curve on home sleep apnea testing or risk being put out of business, according to Dr. Charles W. Atwood Jr., director of the Sleep Disorders Program at the Veterans Affairs Pittsburgh Healthcare System.

Those "who can integrate this are going to survive, and [those] who can’t integrate this are not going to do as well," said Dr. Atwood, who is also an associate professor of medicine at the University of Pittsburgh.

Home sleep apnea testing (HSAT) is gaining traction among U.S. insurers because, among other things, it costs a lot less than traditional sleep lab apnea screening. Physician reimbursement is generally in the range of $180, compared with $700 or so for polysomnography. The Centers for Medicare and Medicaid Services are on board, as well, and have begun reimbursing for HSAT.

HSAT patients hook themselves up before bed to one of several HSAT devices on the market. The monitors typically measure airflow, respiratory effort, and heart rate, and include pulse oximetry. Results are later interpreted in the doctor’s office.

HSAT has only about 10% of the U.S. sleep study market at the moment, "quite small despite all the attention it gets," but with a lower price tag and studies showing that it is a viable alternative to polysomnography, the market is "likely to continue to increase. Most private [insurance] companies are going to want you do to this," Dr. Atwood said at a meeting on sleep medicine sponsored by the American College of Chest Physicians.

Sleep medicine physicians "need to think about companies that want to contract with primary care providers or insurance companies and get an exclusive contract that bars you from doing this kind of work. That has happened in certain markets, and it’s really devastated traditional sleep labs," he said.

Forestalling that means "getting to your insurance companies first and saying, ‘Look, we know this is coming. This is something that we can do. You’ll be happy with our services. Let’s talk,’ " Dr. Atwood said.

In the meantime, "network with your primary care and other referrers to make sure that they know you are doing this. They will want to know who’s going to take care of these patients if they can’t get a traditional sleep study," he said.

Overall, home sleep apnea testing "is not that hard," said Dr. Atwood, who researches HSAT and is a consultant for companies that make the devices.

Pick one system and get to know it well, and start with the easiest, least-complicated patients. Give some thought to who is going to teach patients how to use the devices – how-to videos are available for many – and how to get the devices back after patients are done with them. FedEx and UPS are options.

"You’ll also need to think about what to do with negative studies," he noted. You could take them at face value, repeat the test, or send patients to sleep labs for follow-up.

Home tests won’t work in about 10%-15% of patients, mostly because they will be noncompliant or will slip the pulse oximeter off while asleep. Also, because home testing generates fewer signals than does polysomnography, "you have to get comfortable making decisions with less information," Dr. Atwood said.

Nonetheless, he and his colleagues found that HSAT patients had no worse 3-month functional outcomes and continuous positive airway pressure (CPAP) adherence than did patients whose sleep apnea was diagnosed in a lab (Am. J. Respir. Crit. Care Med. 2011;183:1238-44).

Dr. Atwood receives commercial research support from Philips Respironics, Resmed, Embla, and Vapotherm. He is a consultant to Carecore, Resmed, and Philips Respironics.

Postoperative radiation therapy does not improve the survival of elderly patients following complete resection of stage III non–small cell lung cancer with N2 lymph node involvement, according to a retrospective study of the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) registry linked to Medicare records.

"Clinicians should refrain from widespread use of PORT [postoperative radiation therapy] in elderly patients with this cancer subtype until we know more," especially given its side effects, said lead author and pulmonologist Dr. Juan P. Wisnivesky of the Mount Sinai School of Medicine in New York, and his coauthors.

Although the value of PORT in N2-positive disease has been uncertain, it’s often used in these patients for whom the extent of lymph node involvement greatly affects prognosis. Long-term survival drops from 70% of patients without lymph involvement to 20%-35% of patients with microscopic N2 disease, the authors noted.

More than 54% (710) of the 1,307 patients identified in the SEER-Medicare database received postoperative radiation. They were all diagnosed between 1992 and 2005. Patients who underwent limited resection, received preoperative chemotherapy or radiation therapy, or died with 30 days of surgery were excluded from the current study. The results were published online Feb. 13 in Cancer (2012[doi:10.1002/cncr.26585]).

The investigators reported patients who received PORT tended to be younger and higher in income than those who did not, but otherwise were evenly matched for race, gender, and comorbidities. Nearly half, 42%, of the PORT group was in the group aged 65-70 years, 34% aged 71-75, and 24% older than 75years.

Tumor status, histology, and rates of lobectomy and pneumonectomy were similar whether patients received PORT or not. Patients in the PORT group were more likely to receive adjuvant chemotherapy; however, 36% did so vs. 23% of the group not given PORT.

PORT did not improve 1 or 3-year survival in an unadjusted analysis or in a Cox model adjusting for propensity scores (HR, 1.11; 95% confidence interval 0.97-1.27). "Analyses limited to patients treated with or without chemotherapy" as well as "intermediate or high complexity [radiation therapy] planning ... showed similar results," the researchers noted.

The SEER study "was powered to detect relatively small benefits of PORT," they said. "The generalizability of our results should be excellent"

SEER doesn’t record disease recurrence, so "we were not able to assess whether PORT is associated with...increased disease-free survival or lower rates of local recurrence." Similarly, because the registry does not record total radiation dose or fractionation schedule, "We were not able to assess the impact of these factors on lung cancer survival," the researchers cautioned.

The results are consistent with the conclusions of the PORT Meta-Analysis Trialists Group, which recommended that PORT use be limited to clinical trials until more data are available, the authors wrote. Dr. Wisnivesky, et al. said the results "highlight the importance" of enrolling patients in the ongoing French-sponsored, phase III Lung Adjuvant Radiotherapy Trial, known as Lung Art.

Dr. Wisnivesky has received a research grant from GlaxoSmithKline and lecture honorarium from Novartis. His coauthors reported no relevant conflicts of interest. The study was funded by the National Cancer Institute.

Postoperative radiation therapy does not improve the survival of elderly patients following complete resection of stage III non–small cell lung cancer with N2 lymph node involvement, according to a retrospective study of the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) registry linked to Medicare records.

"Clinicians should refrain from widespread use of PORT [postoperative radiation therapy] in elderly patients with this cancer subtype until we know more," especially given its side effects, said lead author and pulmonologist Dr. Juan P. Wisnivesky of the Mount Sinai School of Medicine in New York, and his coauthors.

Although the value of PORT in N2-positive disease has been uncertain, it’s often used in these patients for whom the extent of lymph node involvement greatly affects prognosis. Long-term survival drops from 70% of patients without lymph involvement to 20%-35% of patients with microscopic N2 disease, the authors noted.

More than 54% (710) of the 1,307 patients identified in the SEER-Medicare database received postoperative radiation. They were all diagnosed between 1992 and 2005. Patients who underwent limited resection, received preoperative chemotherapy or radiation therapy, or died with 30 days of surgery were excluded from the current study. The results were published online Feb. 13 in Cancer (2012[doi:10.1002/cncr.26585]).

The investigators reported patients who received PORT tended to be younger and higher in income than those who did not, but otherwise were evenly matched for race, gender, and comorbidities. Nearly half, 42%, of the PORT group was in the group aged 65-70 years, 34% aged 71-75, and 24% older than 75years.

Tumor status, histology, and rates of lobectomy and pneumonectomy were similar whether patients received PORT or not. Patients in the PORT group were more likely to receive adjuvant chemotherapy; however, 36% did so vs. 23% of the group not given PORT.

PORT did not improve 1 or 3-year survival in an unadjusted analysis or in a Cox model adjusting for propensity scores (HR, 1.11; 95% confidence interval 0.97-1.27). "Analyses limited to patients treated with or without chemotherapy" as well as "intermediate or high complexity [radiation therapy] planning ... showed similar results," the researchers noted.

The SEER study "was powered to detect relatively small benefits of PORT," they said. "The generalizability of our results should be excellent"

SEER doesn’t record disease recurrence, so "we were not able to assess whether PORT is associated with...increased disease-free survival or lower rates of local recurrence." Similarly, because the registry does not record total radiation dose or fractionation schedule, "We were not able to assess the impact of these factors on lung cancer survival," the researchers cautioned.

The results are consistent with the conclusions of the PORT Meta-Analysis Trialists Group, which recommended that PORT use be limited to clinical trials until more data are available, the authors wrote. Dr. Wisnivesky, et al. said the results "highlight the importance" of enrolling patients in the ongoing French-sponsored, phase III Lung Adjuvant Radiotherapy Trial, known as Lung Art.

Dr. Wisnivesky has received a research grant from GlaxoSmithKline and lecture honorarium from Novartis. His coauthors reported no relevant conflicts of interest. The study was funded by the National Cancer Institute.

Postoperative radiation therapy does not improve the survival of elderly patients following complete resection of stage III non–small cell lung cancer with N2 lymph node involvement, according to a retrospective study of the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) registry linked to Medicare records.

"Clinicians should refrain from widespread use of PORT [postoperative radiation therapy] in elderly patients with this cancer subtype until we know more," especially given its side effects, said lead author and pulmonologist Dr. Juan P. Wisnivesky of the Mount Sinai School of Medicine in New York, and his coauthors.

Although the value of PORT in N2-positive disease has been uncertain, it’s often used in these patients for whom the extent of lymph node involvement greatly affects prognosis. Long-term survival drops from 70% of patients without lymph involvement to 20%-35% of patients with microscopic N2 disease, the authors noted.

More than 54% (710) of the 1,307 patients identified in the SEER-Medicare database received postoperative radiation. They were all diagnosed between 1992 and 2005. Patients who underwent limited resection, received preoperative chemotherapy or radiation therapy, or died with 30 days of surgery were excluded from the current study. The results were published online Feb. 13 in Cancer (2012[doi:10.1002/cncr.26585]).

The investigators reported patients who received PORT tended to be younger and higher in income than those who did not, but otherwise were evenly matched for race, gender, and comorbidities. Nearly half, 42%, of the PORT group was in the group aged 65-70 years, 34% aged 71-75, and 24% older than 75years.

Tumor status, histology, and rates of lobectomy and pneumonectomy were similar whether patients received PORT or not. Patients in the PORT group were more likely to receive adjuvant chemotherapy; however, 36% did so vs. 23% of the group not given PORT.

PORT did not improve 1 or 3-year survival in an unadjusted analysis or in a Cox model adjusting for propensity scores (HR, 1.11; 95% confidence interval 0.97-1.27). "Analyses limited to patients treated with or without chemotherapy" as well as "intermediate or high complexity [radiation therapy] planning ... showed similar results," the researchers noted.

The SEER study "was powered to detect relatively small benefits of PORT," they said. "The generalizability of our results should be excellent"

SEER doesn’t record disease recurrence, so "we were not able to assess whether PORT is associated with...increased disease-free survival or lower rates of local recurrence." Similarly, because the registry does not record total radiation dose or fractionation schedule, "We were not able to assess the impact of these factors on lung cancer survival," the researchers cautioned.

The results are consistent with the conclusions of the PORT Meta-Analysis Trialists Group, which recommended that PORT use be limited to clinical trials until more data are available, the authors wrote. Dr. Wisnivesky, et al. said the results "highlight the importance" of enrolling patients in the ongoing French-sponsored, phase III Lung Adjuvant Radiotherapy Trial, known as Lung Art.

Dr. Wisnivesky has received a research grant from GlaxoSmithKline and lecture honorarium from Novartis. His coauthors reported no relevant conflicts of interest. The study was funded by the National Cancer Institute.

A prospective study has confirmed that Lynch syndrome, an inherited disorder that predisposes to many types of cancer, significantly raises the risk of both breast cancer and pancreatic cancer.

The trial is the first to "find a strong association between breast cancer and Lynch syndrome," said senior author and genetic epidemiologist Mark A. Jenkins, Ph.D., of the centre for molecular, environmental, genetic, and analytic epidemiology at the University of Melbourne.

Risk of breast cancer was fourfold higher for the Lynch syndrome patients, compared with the general population. The syndrome is known to increase the risk for a wide variety of other cancers, including colon cancer. Patients are typically advised to begin colonoscopies at an earlier age and repeat them more often than does the general population.

The new findings suggest that women with the syndrome might also benefit from enhanced breast cancer screening, but "further clarification of the risk of breast cancer for women at various ages is needed to determine the recommended age for mammography ... and to determine whether additional tests such as MRI are warranted," Dr. Jenkins said.

The researchers also found an 11-fold increase in pancreatic cancers among the Lynch syndrome patients. Although elevated risk of this cancer has long been suspected, the evidence from previous studies has been inconsistent. The results were published online Feb. 13 in the Journal of Clinical Oncology.

The autosomal dominant disorder, detected with a blood test, is caused by a mutation in one of four DNA mismatch repair (MMR) genes: MLH1, MSH2, MSH6, or PMS2. The estimated carrier frequency in the population ranges from 1 in 360 to 1 in 3,010 individuals, depending on whether all four specific mutations, or fewer than four, are included in the calculations.

Family members without the mutation, however, do not have a greater risk for cancer, and do not need more intensive screening than does the general population – something that has been unclear until now.

The investigators followed 446 mutation carriers and 1,029 noncarrier relatives recruited from the Colon Cancer Family Registry in 1997-2010. Almost all study subjects (96%) were white, and slightly more than half were female. At recruitment, mean age ranged from 40 to 50 years for the different subgroups. The registry includes subjects from the United States, Canada, Australia, and New Zealand.

After a median follow-up of 5 years, mutation carriers had a 20-fold greater risk of colorectal cancer, a 31-fold greater risk of endometrial cancer, a 19-fold higher risk of ovarian cancer, an 11-fold greater risk of renal cancer, and a 10-fold greater risk of stomach and bladder cancers, compared with the general population. The increase in risk for breast and pancreatic cancer was 4-fold and 11-fold, respectively.

For each cancer type, the increased rate in mutation carriers was highly significant, with P values ranging from .009 to less than .001. In addition, the Lynch syndrome patients’ cancer diagnoses typically came at an earlier age than it did in the general population. (J. Clin. Oncol. 2012 Feb. 13 [doi:10.1200/JCO.2011.39.5590]).

"Estimates of site-specific cancer risks for MMR gene mutation carriers inform optimal clinical management," the researchers noted. "Screening colonoscopy, prophylactic hysterectomy, and bilateral salpingo-oophorectomy have the potential to decrease the risk of colorectal cancer, endometrial cancer, and ovarian cancer, respectively."

"Eventually, we expect that the management of cancer risk, including the choice and timing of screening, will be able to be tailored to the specific underlying gene mutation in a person with Lynch syndrome." However, there are no data demonstrating that screening for cancers other than colorectal "is beneficial, in part due to the absence of effective screening tests," Dr. Jenkins and colleagues wrote.

The authors said that they have no relevant conflicts of interest. The study was funded by the National Cancer Institute.

A prospective study has confirmed that Lynch syndrome, an inherited disorder that predisposes to many types of cancer, significantly raises the risk of both breast cancer and pancreatic cancer.

The trial is the first to "find a strong association between breast cancer and Lynch syndrome," said senior author and genetic epidemiologist Mark A. Jenkins, Ph.D., of the centre for molecular, environmental, genetic, and analytic epidemiology at the University of Melbourne.

Risk of breast cancer was fourfold higher for the Lynch syndrome patients, compared with the general population. The syndrome is known to increase the risk for a wide variety of other cancers, including colon cancer. Patients are typically advised to begin colonoscopies at an earlier age and repeat them more often than does the general population.

The new findings suggest that women with the syndrome might also benefit from enhanced breast cancer screening, but "further clarification of the risk of breast cancer for women at various ages is needed to determine the recommended age for mammography ... and to determine whether additional tests such as MRI are warranted," Dr. Jenkins said.

The researchers also found an 11-fold increase in pancreatic cancers among the Lynch syndrome patients. Although elevated risk of this cancer has long been suspected, the evidence from previous studies has been inconsistent. The results were published online Feb. 13 in the Journal of Clinical Oncology.

The autosomal dominant disorder, detected with a blood test, is caused by a mutation in one of four DNA mismatch repair (MMR) genes: MLH1, MSH2, MSH6, or PMS2. The estimated carrier frequency in the population ranges from 1 in 360 to 1 in 3,010 individuals, depending on whether all four specific mutations, or fewer than four, are included in the calculations.

Family members without the mutation, however, do not have a greater risk for cancer, and do not need more intensive screening than does the general population – something that has been unclear until now.

The investigators followed 446 mutation carriers and 1,029 noncarrier relatives recruited from the Colon Cancer Family Registry in 1997-2010. Almost all study subjects (96%) were white, and slightly more than half were female. At recruitment, mean age ranged from 40 to 50 years for the different subgroups. The registry includes subjects from the United States, Canada, Australia, and New Zealand.

After a median follow-up of 5 years, mutation carriers had a 20-fold greater risk of colorectal cancer, a 31-fold greater risk of endometrial cancer, a 19-fold higher risk of ovarian cancer, an 11-fold greater risk of renal cancer, and a 10-fold greater risk of stomach and bladder cancers, compared with the general population. The increase in risk for breast and pancreatic cancer was 4-fold and 11-fold, respectively.

For each cancer type, the increased rate in mutation carriers was highly significant, with P values ranging from .009 to less than .001. In addition, the Lynch syndrome patients’ cancer diagnoses typically came at an earlier age than it did in the general population. (J. Clin. Oncol. 2012 Feb. 13 [doi:10.1200/JCO.2011.39.5590]).

"Estimates of site-specific cancer risks for MMR gene mutation carriers inform optimal clinical management," the researchers noted. "Screening colonoscopy, prophylactic hysterectomy, and bilateral salpingo-oophorectomy have the potential to decrease the risk of colorectal cancer, endometrial cancer, and ovarian cancer, respectively."

"Eventually, we expect that the management of cancer risk, including the choice and timing of screening, will be able to be tailored to the specific underlying gene mutation in a person with Lynch syndrome." However, there are no data demonstrating that screening for cancers other than colorectal "is beneficial, in part due to the absence of effective screening tests," Dr. Jenkins and colleagues wrote.

The authors said that they have no relevant conflicts of interest. The study was funded by the National Cancer Institute.

A prospective study has confirmed that Lynch syndrome, an inherited disorder that predisposes to many types of cancer, significantly raises the risk of both breast cancer and pancreatic cancer.

The trial is the first to "find a strong association between breast cancer and Lynch syndrome," said senior author and genetic epidemiologist Mark A. Jenkins, Ph.D., of the centre for molecular, environmental, genetic, and analytic epidemiology at the University of Melbourne.

Risk of breast cancer was fourfold higher for the Lynch syndrome patients, compared with the general population. The syndrome is known to increase the risk for a wide variety of other cancers, including colon cancer. Patients are typically advised to begin colonoscopies at an earlier age and repeat them more often than does the general population.

The new findings suggest that women with the syndrome might also benefit from enhanced breast cancer screening, but "further clarification of the risk of breast cancer for women at various ages is needed to determine the recommended age for mammography ... and to determine whether additional tests such as MRI are warranted," Dr. Jenkins said.

The researchers also found an 11-fold increase in pancreatic cancers among the Lynch syndrome patients. Although elevated risk of this cancer has long been suspected, the evidence from previous studies has been inconsistent. The results were published online Feb. 13 in the Journal of Clinical Oncology.

The autosomal dominant disorder, detected with a blood test, is caused by a mutation in one of four DNA mismatch repair (MMR) genes: MLH1, MSH2, MSH6, or PMS2. The estimated carrier frequency in the population ranges from 1 in 360 to 1 in 3,010 individuals, depending on whether all four specific mutations, or fewer than four, are included in the calculations.

Family members without the mutation, however, do not have a greater risk for cancer, and do not need more intensive screening than does the general population – something that has been unclear until now.

The investigators followed 446 mutation carriers and 1,029 noncarrier relatives recruited from the Colon Cancer Family Registry in 1997-2010. Almost all study subjects (96%) were white, and slightly more than half were female. At recruitment, mean age ranged from 40 to 50 years for the different subgroups. The registry includes subjects from the United States, Canada, Australia, and New Zealand.

After a median follow-up of 5 years, mutation carriers had a 20-fold greater risk of colorectal cancer, a 31-fold greater risk of endometrial cancer, a 19-fold higher risk of ovarian cancer, an 11-fold greater risk of renal cancer, and a 10-fold greater risk of stomach and bladder cancers, compared with the general population. The increase in risk for breast and pancreatic cancer was 4-fold and 11-fold, respectively.

For each cancer type, the increased rate in mutation carriers was highly significant, with P values ranging from .009 to less than .001. In addition, the Lynch syndrome patients’ cancer diagnoses typically came at an earlier age than it did in the general population. (J. Clin. Oncol. 2012 Feb. 13 [doi:10.1200/JCO.2011.39.5590]).

"Estimates of site-specific cancer risks for MMR gene mutation carriers inform optimal clinical management," the researchers noted. "Screening colonoscopy, prophylactic hysterectomy, and bilateral salpingo-oophorectomy have the potential to decrease the risk of colorectal cancer, endometrial cancer, and ovarian cancer, respectively."

"Eventually, we expect that the management of cancer risk, including the choice and timing of screening, will be able to be tailored to the specific underlying gene mutation in a person with Lynch syndrome." However, there are no data demonstrating that screening for cancers other than colorectal "is beneficial, in part due to the absence of effective screening tests," Dr. Jenkins and colleagues wrote.

The authors said that they have no relevant conflicts of interest. The study was funded by the National Cancer Institute.

PHOENIX – Reducing bedtime stimulation and, oddly enough, restricting sleep both have powerful, relatively fast effects on insomnia, especially when used in tandem.

Among cognitive-behavioral therapy approaches, they have the best supporting evidence and, "happily, are the easiest to do," said Allison Harvey, Ph.D., director of the University of California, Berkeley, Golden Bear Sleep and Mood Research Clinic.

Copyright YinYang/iStockphoto.com

The goal is to teach insomniacs that their beds are for sleeping, not watching TV, surfing the Net, eating potato chips, or fretting about not getting enough sleep.

Sleep restriction limits their time in bed to the time they actually sleep. The first step is to discover that ratio by having patients keep a sleep diary for a week or 2. Insomniacs are usually about 60% sleep efficient; for every 8 hours in bed, they’ll sleep about 5.

The next step is limiting bed time to sleep time. At first, that might cause a bit of sleep deprivation, but that’s a good thing because it builds homeostatic pressure to sleep, Dr. Harvey said.

The goal is 85% sleep efficiency; 4.25 hours of sleep, for instance, for every 5 hours in bed. As long as patients remain 85% efficient, time in bed can be increased by 15 minutes every 5 or so days. Within about 6 weeks, patients should be getting an efficient 7 or 8 hours of sleep per night.

At first, "we never go less than 5 hours a night" and "make the determination of how low we go dependent on safety issues. So, if someone’s a truck driver, we probably wouldn’t do this treatment. If someone has bipolar disorder, I wouldn’t go below 6½ hours because sleep deprivation can trigger a manic episode." Naps are okay if needed, so long as they are before 3 p.m. and are 30 minutes or less, Dr. Harvey said.

Stimulus control reinforces the bed-sleep connection. If patients aren’t asleep within 20 minutes, "Don’t let them clock watch. [Tell them to] get up and move to another room, and stay up until they are really sleepy," she said.

If they want to read, it shouldn’t be something that will keep them up all night. If they want to watch TV, it should be something relaxing, not channel surfing. If they’re anxious, writing in a journal can help.

"I had one patient who said, ‘Oh, I can get some housework done.’ No. Nothing productive. Other patients say, ‘I can get on my computer and do some e-mail.’ No; [they need] dim light conditions," Dr. Harvey said.

Flexibility is important. Some patients might want to restrict sleep in the evening, others in the morning. Both are fine. Some patients might worry that 5 hours is too little bedtime, so "start with 7½; it’s better than 8½. Sleep efficiency will pop up a bit, they’ll get confidence. They’ll come down to seven hours the next week. Just base it on what makes sense for the person," Dr. Harvey said.

It might take a few weeks for patients to see benefits, so support is important, too. Troubleshoot their routine for problems, and encourage them to continue the program, she said.

It’s uncertain what benefit sedative hypnotics such as zolpidem (Ambien) would add to the approach, she noted.

Dr. Harvey reported having no relevant financial disclosures.

PHOENIX – Reducing bedtime stimulation and, oddly enough, restricting sleep both have powerful, relatively fast effects on insomnia, especially when used in tandem.

Among cognitive-behavioral therapy approaches, they have the best supporting evidence and, "happily, are the easiest to do," said Allison Harvey, Ph.D., director of the University of California, Berkeley, Golden Bear Sleep and Mood Research Clinic.

Copyright YinYang/iStockphoto.com

The goal is to teach insomniacs that their beds are for sleeping, not watching TV, surfing the Net, eating potato chips, or fretting about not getting enough sleep.

Sleep restriction limits their time in bed to the time they actually sleep. The first step is to discover that ratio by having patients keep a sleep diary for a week or 2. Insomniacs are usually about 60% sleep efficient; for every 8 hours in bed, they’ll sleep about 5.

The next step is limiting bed time to sleep time. At first, that might cause a bit of sleep deprivation, but that’s a good thing because it builds homeostatic pressure to sleep, Dr. Harvey said.

The goal is 85% sleep efficiency; 4.25 hours of sleep, for instance, for every 5 hours in bed. As long as patients remain 85% efficient, time in bed can be increased by 15 minutes every 5 or so days. Within about 6 weeks, patients should be getting an efficient 7 or 8 hours of sleep per night.

At first, "we never go less than 5 hours a night" and "make the determination of how low we go dependent on safety issues. So, if someone’s a truck driver, we probably wouldn’t do this treatment. If someone has bipolar disorder, I wouldn’t go below 6½ hours because sleep deprivation can trigger a manic episode." Naps are okay if needed, so long as they are before 3 p.m. and are 30 minutes or less, Dr. Harvey said.

Stimulus control reinforces the bed-sleep connection. If patients aren’t asleep within 20 minutes, "Don’t let them clock watch. [Tell them to] get up and move to another room, and stay up until they are really sleepy," she said.

If they want to read, it shouldn’t be something that will keep them up all night. If they want to watch TV, it should be something relaxing, not channel surfing. If they’re anxious, writing in a journal can help.

"I had one patient who said, ‘Oh, I can get some housework done.’ No. Nothing productive. Other patients say, ‘I can get on my computer and do some e-mail.’ No; [they need] dim light conditions," Dr. Harvey said.

Flexibility is important. Some patients might want to restrict sleep in the evening, others in the morning. Both are fine. Some patients might worry that 5 hours is too little bedtime, so "start with 7½; it’s better than 8½. Sleep efficiency will pop up a bit, they’ll get confidence. They’ll come down to seven hours the next week. Just base it on what makes sense for the person," Dr. Harvey said.

It might take a few weeks for patients to see benefits, so support is important, too. Troubleshoot their routine for problems, and encourage them to continue the program, she said.

It’s uncertain what benefit sedative hypnotics such as zolpidem (Ambien) would add to the approach, she noted.

Dr. Harvey reported having no relevant financial disclosures.

PHOENIX – Reducing bedtime stimulation and, oddly enough, restricting sleep both have powerful, relatively fast effects on insomnia, especially when used in tandem.

Among cognitive-behavioral therapy approaches, they have the best supporting evidence and, "happily, are the easiest to do," said Allison Harvey, Ph.D., director of the University of California, Berkeley, Golden Bear Sleep and Mood Research Clinic.

Copyright YinYang/iStockphoto.com

The goal is to teach insomniacs that their beds are for sleeping, not watching TV, surfing the Net, eating potato chips, or fretting about not getting enough sleep.

Sleep restriction limits their time in bed to the time they actually sleep. The first step is to discover that ratio by having patients keep a sleep diary for a week or 2. Insomniacs are usually about 60% sleep efficient; for every 8 hours in bed, they’ll sleep about 5.

The next step is limiting bed time to sleep time. At first, that might cause a bit of sleep deprivation, but that’s a good thing because it builds homeostatic pressure to sleep, Dr. Harvey said.

The goal is 85% sleep efficiency; 4.25 hours of sleep, for instance, for every 5 hours in bed. As long as patients remain 85% efficient, time in bed can be increased by 15 minutes every 5 or so days. Within about 6 weeks, patients should be getting an efficient 7 or 8 hours of sleep per night.

At first, "we never go less than 5 hours a night" and "make the determination of how low we go dependent on safety issues. So, if someone’s a truck driver, we probably wouldn’t do this treatment. If someone has bipolar disorder, I wouldn’t go below 6½ hours because sleep deprivation can trigger a manic episode." Naps are okay if needed, so long as they are before 3 p.m. and are 30 minutes or less, Dr. Harvey said.

Stimulus control reinforces the bed-sleep connection. If patients aren’t asleep within 20 minutes, "Don’t let them clock watch. [Tell them to] get up and move to another room, and stay up until they are really sleepy," she said.

If they want to read, it shouldn’t be something that will keep them up all night. If they want to watch TV, it should be something relaxing, not channel surfing. If they’re anxious, writing in a journal can help.

"I had one patient who said, ‘Oh, I can get some housework done.’ No. Nothing productive. Other patients say, ‘I can get on my computer and do some e-mail.’ No; [they need] dim light conditions," Dr. Harvey said.

Flexibility is important. Some patients might want to restrict sleep in the evening, others in the morning. Both are fine. Some patients might worry that 5 hours is too little bedtime, so "start with 7½; it’s better than 8½. Sleep efficiency will pop up a bit, they’ll get confidence. They’ll come down to seven hours the next week. Just base it on what makes sense for the person," Dr. Harvey said.

It might take a few weeks for patients to see benefits, so support is important, too. Troubleshoot their routine for problems, and encourage them to continue the program, she said.

It’s uncertain what benefit sedative hypnotics such as zolpidem (Ambien) would add to the approach, she noted.

Dr. Harvey reported having no relevant financial disclosures.

PHOENIX – When patients’ sleep cycles are out of synch with the rest of the world, melatonin and light therapy can help.

But for night owls – people who fall asleep at 5 a.m. and awake at noon, for instance – it’s important to use a low dose of melatonin, 0.5-1 mg, and it should be given around 7 p.m., 4-5 hours before their desired sleep time, according to Dr. Phyllis Zee, associate director of the Northwestern University Center for Sleep and Circadian Biology in Evanston, Ill.

Bedtime "is not when you give melatonin," she said. And a small dose is better than a larger one for moving internal sleep clocks forward and less likely to make people sleepy in the early evening.

Night owl patients are clinically described as having a delayed sleep phase disorder, a circadian rhythm problem. Bright light therapy in the early morning, around the time when they would like to wake up, also helps, sometimes in just a few sessions.

Light and melatonin have strong, but opposite, effects on the suprachiasmatic nucleus (SCN), thought to be the brain’s internal clock. Light, especially blue light, increases SCN firing, alerting the body. Melatonin, secreted by the pineal gland under SCN control on a 24-hour cycle, decreases SCN firing, promoting sleep.

Dim light triggers melatonin secretion; endogenous levels begin to rise about 2 hours before sleep, a phenomenon known as dim-light melatonin onset (DLMO). Melatonin supplements help the rise come earlier in night owls, who should also avoid bright light in the evening.

The role of melatonin is uncertain in people with an advanced sleep phase disorder – those who routinely fall asleep at 7 p.m., for instance, and awake at 4 a.m. – but bright light therapy early in the evening can push back their sleep schedule, also in just a few sessions. "In someone with advanced sleep phase, that’s what I would do first. Bright light therapy in the evening," Dr. Zee said

Patients with circadian sleep disorders don’t have insomnia. Once asleep, they get a full night’s rest.

Even so, being out of synch with the world can cause problems. People with delayed phase disorders can barely get out bed for work, and when they do, they’re sleepy all day. An advanced-phase person’s internal clock tells that person to go to bed when the rest of the world is still active. Such misalignments can trigger actual insomnia and lead to health problems. Delayed phase disorders also correlate with depression.

"Many people who we think have primary insomnia or psychological insomnia actually have delayed or advanced circadian phases. It isn’t so much they complain about insomnia; they really complain about excessive sleepiness," Dr. Zee said.

To make the right therapeutic call, it’s important to know the timing of patients’ internal clocks. History gives a clue. "I’ve never met a delayed person who is not an owl. I’ve never met an advance sleep phase disorder person who is not a lark," Dr. Zee said.

A sleep diary helps, too, along with actigraphy, which involves recording wrist activity with a watch-like device worn over several days. It gives a good idea of sleep/wake activity.

DLMO can be accessed directly as well, at least in a sleep lab. In dim light, patients are asked to chew a cotton ball every half hour for 24 hours. Melatonin concentrations are assessed from the saliva. DLMO usually comes at about 9 p.m. for someone on an 11 p.m.-7 a.m. sleep schedule.

Dr. Zee is a consultant for Sanofi-Aventis, Merck, Johnson & Johnson, UCB Pharma, Purdue Pharma, Jazz Pharmaceuticals, and Royal Philips Electronics/Respironics. She also disclosed stock options in Zeo.

PHOENIX – When patients’ sleep cycles are out of synch with the rest of the world, melatonin and light therapy can help.

But for night owls – people who fall asleep at 5 a.m. and awake at noon, for instance – it’s important to use a low dose of melatonin, 0.5-1 mg, and it should be given around 7 p.m., 4-5 hours before their desired sleep time, according to Dr. Phyllis Zee, associate director of the Northwestern University Center for Sleep and Circadian Biology in Evanston, Ill.

Bedtime "is not when you give melatonin," she said. And a small dose is better than a larger one for moving internal sleep clocks forward and less likely to make people sleepy in the early evening.

Night owl patients are clinically described as having a delayed sleep phase disorder, a circadian rhythm problem. Bright light therapy in the early morning, around the time when they would like to wake up, also helps, sometimes in just a few sessions.

Light and melatonin have strong, but opposite, effects on the suprachiasmatic nucleus (SCN), thought to be the brain’s internal clock. Light, especially blue light, increases SCN firing, alerting the body. Melatonin, secreted by the pineal gland under SCN control on a 24-hour cycle, decreases SCN firing, promoting sleep.

Dim light triggers melatonin secretion; endogenous levels begin to rise about 2 hours before sleep, a phenomenon known as dim-light melatonin onset (DLMO). Melatonin supplements help the rise come earlier in night owls, who should also avoid bright light in the evening.

The role of melatonin is uncertain in people with an advanced sleep phase disorder – those who routinely fall asleep at 7 p.m., for instance, and awake at 4 a.m. – but bright light therapy early in the evening can push back their sleep schedule, also in just a few sessions. "In someone with advanced sleep phase, that’s what I would do first. Bright light therapy in the evening," Dr. Zee said

Patients with circadian sleep disorders don’t have insomnia. Once asleep, they get a full night’s rest.

Even so, being out of synch with the world can cause problems. People with delayed phase disorders can barely get out bed for work, and when they do, they’re sleepy all day. An advanced-phase person’s internal clock tells that person to go to bed when the rest of the world is still active. Such misalignments can trigger actual insomnia and lead to health problems. Delayed phase disorders also correlate with depression.

"Many people who we think have primary insomnia or psychological insomnia actually have delayed or advanced circadian phases. It isn’t so much they complain about insomnia; they really complain about excessive sleepiness," Dr. Zee said.

To make the right therapeutic call, it’s important to know the timing of patients’ internal clocks. History gives a clue. "I’ve never met a delayed person who is not an owl. I’ve never met an advance sleep phase disorder person who is not a lark," Dr. Zee said.

A sleep diary helps, too, along with actigraphy, which involves recording wrist activity with a watch-like device worn over several days. It gives a good idea of sleep/wake activity.

DLMO can be accessed directly as well, at least in a sleep lab. In dim light, patients are asked to chew a cotton ball every half hour for 24 hours. Melatonin concentrations are assessed from the saliva. DLMO usually comes at about 9 p.m. for someone on an 11 p.m.-7 a.m. sleep schedule.

Dr. Zee is a consultant for Sanofi-Aventis, Merck, Johnson & Johnson, UCB Pharma, Purdue Pharma, Jazz Pharmaceuticals, and Royal Philips Electronics/Respironics. She also disclosed stock options in Zeo.

PHOENIX – When patients’ sleep cycles are out of synch with the rest of the world, melatonin and light therapy can help.

But for night owls – people who fall asleep at 5 a.m. and awake at noon, for instance – it’s important to use a low dose of melatonin, 0.5-1 mg, and it should be given around 7 p.m., 4-5 hours before their desired sleep time, according to Dr. Phyllis Zee, associate director of the Northwestern University Center for Sleep and Circadian Biology in Evanston, Ill.

Bedtime "is not when you give melatonin," she said. And a small dose is better than a larger one for moving internal sleep clocks forward and less likely to make people sleepy in the early evening.

Night owl patients are clinically described as having a delayed sleep phase disorder, a circadian rhythm problem. Bright light therapy in the early morning, around the time when they would like to wake up, also helps, sometimes in just a few sessions.

Light and melatonin have strong, but opposite, effects on the suprachiasmatic nucleus (SCN), thought to be the brain’s internal clock. Light, especially blue light, increases SCN firing, alerting the body. Melatonin, secreted by the pineal gland under SCN control on a 24-hour cycle, decreases SCN firing, promoting sleep.

Dim light triggers melatonin secretion; endogenous levels begin to rise about 2 hours before sleep, a phenomenon known as dim-light melatonin onset (DLMO). Melatonin supplements help the rise come earlier in night owls, who should also avoid bright light in the evening.

The role of melatonin is uncertain in people with an advanced sleep phase disorder – those who routinely fall asleep at 7 p.m., for instance, and awake at 4 a.m. – but bright light therapy early in the evening can push back their sleep schedule, also in just a few sessions. "In someone with advanced sleep phase, that’s what I would do first. Bright light therapy in the evening," Dr. Zee said

Patients with circadian sleep disorders don’t have insomnia. Once asleep, they get a full night’s rest.

Even so, being out of synch with the world can cause problems. People with delayed phase disorders can barely get out bed for work, and when they do, they’re sleepy all day. An advanced-phase person’s internal clock tells that person to go to bed when the rest of the world is still active. Such misalignments can trigger actual insomnia and lead to health problems. Delayed phase disorders also correlate with depression.

"Many people who we think have primary insomnia or psychological insomnia actually have delayed or advanced circadian phases. It isn’t so much they complain about insomnia; they really complain about excessive sleepiness," Dr. Zee said.

To make the right therapeutic call, it’s important to know the timing of patients’ internal clocks. History gives a clue. "I’ve never met a delayed person who is not an owl. I’ve never met an advance sleep phase disorder person who is not a lark," Dr. Zee said.

A sleep diary helps, too, along with actigraphy, which involves recording wrist activity with a watch-like device worn over several days. It gives a good idea of sleep/wake activity.

DLMO can be accessed directly as well, at least in a sleep lab. In dim light, patients are asked to chew a cotton ball every half hour for 24 hours. Melatonin concentrations are assessed from the saliva. DLMO usually comes at about 9 p.m. for someone on an 11 p.m.-7 a.m. sleep schedule.

Dr. Zee is a consultant for Sanofi-Aventis, Merck, Johnson & Johnson, UCB Pharma, Purdue Pharma, Jazz Pharmaceuticals, and Royal Philips Electronics/Respironics. She also disclosed stock options in Zeo.