Nasal Orexin for Sleepiness

Wired.com reports on an experimental orexin nasal spray that combats sleepiness. Orexin deficiency is the main cause of narcolepsy with cataplexy. This sounds like a promising treatment for narcolepsy and idiopathic hypersomnia. I do not think this would be an appropriate treatment for voluntary sleep deprivation (except perhaps in the military):
Darpa-funded scientists might have found a drug that will eliminate sleepiness.
A nasal spray containing a naturally occurring brain hormone called orexin A reversed the effects of sleep deprivation in monkeys, allowing them to perform like well-rested monkeys on cognitive tests. The discovery's first application will probably be in treatment of the severe sleep disorder narcolepsy.
"It reduces sleepiness without causing edginess."
Orexin A is a promising candidate to become a "sleep replacement" drug. For decades, stimulants have been used to combat sleepiness, but they can be addictive and often have side effects, including raising blood pressure or causing mood swings.
The monkeys were deprived of sleep for 30 to 36 hours and then given either orexin A or a saline placebo before taking standard cognitive tests. The monkeys given orexin A in a nasal spray scored about the same as alert monkeys, while the saline-control group was severely impaired.
The study, published in the Dec. 26 edition of The Journal of Neuroscience, found orexin A not only restored monkeys' cognitive abilities but made their brains look "awake" in PET scans.
Siegel said that orexin A is unique in that it only had an impact on sleepy monkeys, not alert ones, and that it is "specific in reversing the effects of sleepiness" without other impacts on the brain.
Such a product could be widely desired by the more than 70 percent of Americans who the National Sleep Foundation estimates get less than the generally recommended eight hours of sleep per night
The research follows the discovery by Siegel that the absence of orexin A appears to cause narcolepsy. That finding pointed to a major role for the peptide's absence in causing sleepiness. It stood to reason that if the deficit of orexin A makes people sleepy, adding it back into the brain would reduce the effects, said Siegel.
"What we've been doing so far is increasing arousal without dealing with the underlying problem," he said. "If the underlying deficit is a loss of orexin, and it clearly is, then the best treatment would be orexin."
Dr. Michael Twery, director of the National Center on Sleep Disorders Research, said that while research into drugs for sleepiness is "very interesting," he cautioned that the long-term consequences of not sleeping were not well-known.
Both Twery and Siegel noted that it is unclear whether or not treating the brain chemistry behind sleepiness would alleviate the other problems associated with sleep deprivation.
"New research indicates that not getting enough sleep is associated with increased risk of cardiovascular disease and metabolic disorders," said Twery.
Still, Siegel said that Americans already recognize that sleepiness is a problem and have long treated it with a variety of stimulants.
"We have to realize that we are already living in a society where we are already self-medicating with caffeine," he said.
He also said that modafinil, which is marketed as Provigil by Cephalon and Alertec in Canada, has become widely used by healthy individuals for managing sleepiness.
"We have these other precedents, and it's not clear that you can't use orexin A temporarily to reduce sleep," said Siegel. "On the other hand, you'd have to be a fool to advocate taking this and reducing sleep as much as possible."
Sleep advocates probably won't have to worry about orexin A reaching drugstore shelves for many years. Any commercial treatment using the substance would need approval from the Food and Drug Administration, which can take more than a decade.

Home Testing Comments

Interested in commenting on home testing for OSA? Here is the link:

http://www.cms.hhs.gov/mcd/viewpubliccomments.asp?nca_id=204&rangebegin=12_14_2007&rangeend=01_13_2008

Or you can just read the comments others have made to CMS.

AASM Holiday Sleep Tips

AASM Issues Holiday Sleep Tips (via Sleep Review)
Rest of Sleep Review quote deleted, due to their request
Chediak offers these suggestions for better sleep during the holiday season:
• Take time to relax, and ensure time to wind down before bed.• Keep a regular sleep schedule. Maintain a regular bedtime and wake-up time. Other regular rituals, such as a warm bath, a light snack or a few minutes of reading, also may help.• Plan ahead for holiday activities. Set aside time earlier in the day to wrap gifts, decorate the house, plan your holiday menu, and do similar tasks. To stay on track, write these “appointments” in a daily planner.• Drowsy drivers should pull off to a rest area and take a short nap, preferably 15 to 20 minutes in length.• Do not eat heavy meals right before bedtime. This might cause heartburn or discomfort, which can disturb sleep.• Love eggnog? Avoid too much alcoholic eggnog or coffee at evening holiday parties. Alcohol and caffeine can inhibit normal sleep patterns.

IDTF's can no longer perform sleep studies in hotels

Sleep Review reports that:
Hotels/Motels Not Appropriate for Sleep Studies, CMS Says
New regulatory standards for independent diagnostic testing facilities released by CMS last month are scheduled to take effect January 1, 2008.
Among the standards is one that rules out the use of hotels and motels for performing sleep studies.
For more info, see here.
I believe that this ruling only applies to IDTF's. As an AASM accreditation site visitor, I have inspected a university-owned sleep lab that was based in a hotel. It was a nice operation. I don't agree with this CMS decision, though it will affect only a few sleep labs.

More on home testing for sleep apnea

Sleep Review Magazine reports on home testing for osa:
Last week, home testing took a step closer to becoming a covered benefit under CMS....
deleted upon request of Sleep Review Magazine.
reimbursement criteriaRead the entire announcement by clicking here.

Portable Monitoring Webinar

From the American Academy of Sleep Medicine website:

Get an in-depth overview of the new guidelines for portable monitoring and answers to frequently asked questions by registering for Portable Monitoring Discussion Forum.
AASM Portable Monitoring Task Force chair Nancy Collop, MD, will lead this 60-minute Webinar on December 18, 2007, at 12 p.m. CST. Please note that registrants must submit questions in advance to rrosenberg@aasmnet.org. The deadline to submit questions has been extended to 5 p.m. CST, December 14, 2007.
Log on to www.aasmnet.org/SleepEdSeries.aspx to register for Portable Monitoring Discussion Forum.
The new guideline will be published in the December issue of the Journal of Clinical Sleep Medicine; visit www.aasmnet.org/PortableMonitoring.aspx for comprehensive information.

Preliminary Approval for Home Testing for OSA

Home testing for OSA preliminarly approved: http://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?from2=viewdraftdecisionmemo.asp&id=204&

Not only were type 2 (unattended polysomnogram) and type 3 devices (four channel) approved, but unexpectedly type 4 (1 or 2 channel) devices were also approved.

I am glad that I sold off my shares of Sleep Holdings Inc last week. I wish I would have bought Respironics instead of Resmed on Friday- Respironics makes the superior pulse oximeter (type 4 device)- the 920 M series.

Organized Medicine Endorses Home Testing

I've previously blogged in depth about the American Academy of Sleep Medicine endorsing home testing for the diagnosis of obstructive sleep apnea. Now the American Board of Internal Medicine has also (implicitly) endorsed it:

The ability to interpret results of polysomnography multiple sleep latency testing, maintenance of wakefulness testing, actigraphy, and portable monitoring related to sleep disorders.The ability to interpret results of polysomnography multiple sleep latency testing, maintenance of wakefulness testing, actigraphy, and portable monitoring related to sleep disorders.
From the ABIM website, training and procedural requirements for sleep medicine certification

The preliminary decision from the Center for Medicare Services regarding home testing for osa is expected today.

Sleep Lab Busted by Medicare

Sleep Review magazine reports that HMS Diagnostics Inc was recently busted by CMS (Medicare) for having uncertified technicians run sleep studies on Medicare patients:
Sleep Lab Medicare Claims Under Investigation
According to the release, the US Attorney's Office seems to be suggesting that any CPT 98510 or CPT 98511 study not actually performed by a credentialed technician cannot be billed. The fact that the credentialed technician is on site and supervising apparently is not a factor, HMS Diagnostics stated in the release.
Rest of quote from Sleep Review article deleted, due to their request
“If what CMS is saying is true, then the amount of money that would be owed to Medicare by the industry is phenomenal,” says Goodman. “The liability potential on an industry such as ours with Medicare could be a very big number.”
This is a disturbing development. The requirement for tech certification is virtually unknown in the sleep community. On the AASM message boards, we were recently discussing a new CMS regulation that All studies are to be done by a certified polysomnographer by January 1, 2008 in Arkansas, Louisiana, Eastern Missouri, New Mexico, and Oklahoma and by October 1, 2008 in Rhode Island; and the consensus was that uncertified technicians were ok for the time being in most other states. Most sleep labs have a combination of certified and uncertified techs, and I agree with the article that if CMS is going to enforce this newly discovered regulation, the amount of money owed would be phenomenal.

More on Portable Home Testing and Auto-CPAP

In response to a reader who emailed regarding my predictions of cpap vs. auto-cpap useage:

I don't think that APAP will entirely replace CPAP, but its marketshare will increase somewhat. This will be good for Respironics/RESmed, and bad for the durable medical equipment companies (DME's are reimbursed the same for cpap/auto-cpap machines and therefore there is a higher profit margin on the regular cpap machines for the DME companies). APAP will be prescribed in certain rural areas of the country by some primary care docs. After diagnosing a patient with portable home testing, they will tend to prescribe an auto-cpap machine rather than refer their patients to a sleep lab for a cpap titration. This will have little economic effect on the primary care doc, they will do this to maintain control of the process and maintain their independence from sleep labs. Some primary care docs, especially family practitioners in rural areas, take pride in being able to handle most problems themselves rather than referring to specialists.