U.S. Army Researchers: Major Win in the Battle for Oral Appliance Legitimacy

U.S Army researchers recently cast a spotlight on adjustable oral appliances, with results of their study published in the Journal CHEST, titled “Efficacy of an Adjustable Oral Appliance and Comparison to Continuous Positive Airway Pressure for the Treatment of Obstructive Sleep Apnea Syndrome,” where they evaluated and compared results of overnight sleep studies in which patients used adjustable OAs or CPAP devices. Results were measured by the apnea-hypopnea index (AHI) score, used to assess the severity of sleep apnea based on the total number of complete cessations (apnea) and partial obstructions (hypoapnea) of breathing that last for at least 10 seconds per hour of sleep. The researchers found that a significantly higher percentage of patients using an adjustable OA experienced successful reduction of their AHI score to below five apneic events per hour in this study compared to past reports (62.3 percent versus 54 percent).

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What are the implications for soldiers and civilians? Not surprisingly, the quality of sleep among soldiers can be a shambles during combat deployment. Explosions and less-than-ideal sleeping arrangements are unavoidable, but combine it all with sleep apnea and things get even worse. “We know that most injuries are not battle related,” says Lieutenant Colonel Christopher J. Lettieri, MD, FACP, FCCP, FAASM, a lead author of the study. “We have accidents, and if soldiers are sleep deprived, they are going to lack focus and be more prone to accidents.”

It’s also a problem on U.S. roadways, but the stakes are even higher when lethal machinery is mixed in. “If you are driving a 40-ton tank around, you can’t afford to make bad decisions,” adds Lettieri, program director, Sleep Medicine Fellowship, Walter Reed National Military Medical Center, Washington, DC. “Research shows that chronic low-level sleep deprivation impairs reasoning, decision-making, and slows reaction time. You don’t want that in a combat-deployed troop.”

Oral appliances can fit easily in a ruck sack, but do they actually work? Lettieri and his co-researchers decided to try their own study in an effort to add to the growing literature. Beyond the obvious benefits of reduced accidents, they found that even post traumatic stress disorder (PTSD) may be affected by poor sleep. “We have all these guys coming back with PTSD, and we broke it down into guys who were injured, and those who were not,” explains Lettieri. “Among guys who did not sustain a combat injury, almost universally they had some underlying sleep disorder.”

In the full in-depth interview, published in the Feb/Mar issue of Sleep Diagnosis and Therapy, the two lead authors Lt Col. Lettieri  and Major Aaron B. Holley, MD, FACP, discuss the study’s impact now that it has been in the public domain since late last year, and review the major findings and implications.

Source: SleepScholar

Sleep Labs Need to Offer More than just Overnight Testing

Overnight Sleep testing can be a lucrative business, and labs have popped up in free-standing clinics and hospitals across the country. Over the past decade, the number of accredited sleep labs that test for the disorder has quadrupled, according to the American Academy of Sleep Medicine. At the same time, insurer spending on the procedure has skyrocketed. Medicare payments for sleep testing increased from $62 million in 2001 to $235 million in 2009, according to the Office of the Inspector General.

Dr. Fred Holt, an expert on fraud and abuse and a medical director of Blue Cross Blue Shield in North Carolina, says some patients aren’t having basic exams done first and are therefore being prescribed expensive tests they don’t need. Not everyone who snores has a chronic disorder, he says. In other cases, Holt says, the labs prescribe CPAP machines right away without first suggesting other strategies that could reduce apnea, such as losing weight or sleeping on your side.

While many sleep centers offer comprehensive care for sleep disorders, others are largely focused on overnight sleep testing, according to Nancy Collop M.D., president of the American Academy of Sleep Medicine. “A lot of people have gotten into the sleep business specifically to do that procedure,” she says. The goal of the academy’s accreditation process, she says, is to make sure sleep labs are offering more, because “many patients may not even need a sleep study.”

Source: Read/Listen to the full story on NPR

FAA Issues Final Rule on Pilot Fatigue – Includes Sleep Related Components


Late last month, the FAA released its new flight and duty time rules for airline pilots. Designed to combat on-the-job fatigue, the rules take effect in two years.

The Department of Transportation identified the issue of pilot fatigue as a top priority during a 2009 airline Safety Call to Action following the crash of Colgan Air flight 3407. The FAA launched an aggressive effort to take advantage of the latest research on fatigue to create a new pilot flight, duty and rest proposal, which the agency issued on September 10, 2010.

A couple of sleep related components of this final rule for commercial passenger flights include:

10-hour minimum rest period: The rule sets a 10-hour minimum rest period prior to the flight duty period, a two-hour increase over the old rules. The new rule also mandates that a pilot must have an opportunity for eight hours of uninterrupted sleep within the 10-hour rest period.

Fatigue Management: Required training updates every two years will include fatigue mitigation measures, sleep fundamentals and the impact to a pilot’s performance.  The training will also address how fatigue is influenced by lifestyle – including nutrition, exercise, and family life – as well as by sleep disorders and the impact of commuting.

The final rule has been sent to the Federal Register for display and publication. It is currently available at:http://www.faa.gov/regulations_policies/rulemaking/recently_published/media/2120-AJ58-FinalRule.pdf, and will take effect in two years to allow commercial passenger airline operators time to transition.

A fact sheet with additional information is at http://www.faa.gov/news/fact_sheets/

Solar Recharger Builds Buzz at Transcend

In a universe of savvy competitors, Somnetics International has managed to carve its niche in the CPAP galaxy with a nimble culture, a healthy dose of innovation, and most recently a little help from a rather large star.

After the Transcend gained attention as the smallest and lightest CPAP, engineers at Somnetics International examined the mobile theme yet again, focusing their energies on the crucial battery. The Minnesota-based company ultimately created a solar battery recharger, an innovation that earned the Provider’s Choice award at Medtrade Spring 2012.

Tentatively called the Transcend Portable Solar Charger, the 30 inch × 22 inch device resembles a soft quilt, able to be folded and put into a suitcase or backpack. According to Eric Becker, Engineering Manager at Somnetics, additional modifications are possible before the product officially goes on the market. “At this point, we are making sure we have a full understanding of how fast these batteries will charge in non-ideal conditions,” explains Becker. “We don’t want someone to buy this, go out and charge his battery, and have it die in 4 or 5 hours.”

Beyond these last few tests, essentials such as charger circuitry and safety controls are in place. The product is ready to go, but Becker is determined to leave no stone unturned. If all goes well, he predicts official release at the end of June, following the Associated Professional Sleep Societies (APSS) show in Boston.

Stars are Aligned

Young, aggressive, and driven are all words that accurately describe Somnetics, a relatively new company that embraces a nimble culture. “We do happen to have a lot of young talent,” says the 26-year-old Becker. “Regardless of experience, our engineers don’t have the mindset that they can’t get things done. They push for these projects and have a personal investment in the projects.”

The Transcend Portable Solar Charger is one of those projects with a fast turn-around that came off the wish list generated by patient and clinician feedback. Part of an ambitious goal to release something new every 3 months, the plan to harness the sun’s rays seemed like the perfect complement to the travel CPAP niche.

Users can plug the CPAP unit into the wall anywhere and/ or use a battery that charges in the traditional manner (plus a back-up feed), but what if someone is traveling for a week or two? What if the area is somewhat remote, without ready access to traditional recharging?

The massive awareness of sleep disorders has penetrated into the younger population, and suddenly the idea of backpacking CPAP users is not so farfetched. Once Becker and his colleagues had the vision, they went searching for answers, working with solar vendors to solve the inherent challenges of an inconsistent power source.

On the other side of the argument, the so-called “inconsistent” power source could, in fact, be counted on every day—though the relative intensity would vary. “It’s a variable current,” muses Becker. “How can we charge a lithium ion battery and charge fast enough so that we can charge this every day and use the CPAP for 8 hours a night? We continued to meet with several companies, and we found a company based in Ames, Iowa, that could help us. (PowerFilm, Inc.)”

Avoiding a Meltdown

Becker encountered many issues with solar design, including the limitations of lithium ion battery cells that require a specific voltage, and a specific limit on current. “You also must have temperature controls to ensure that you don’t encounter thermal runaway, and that the batteries don’t melt down and cause a hazard for users,” explains Becker. “Next is how can we use our battery design as it is today with a solar panel given the safety concerns and regulatory controls on the cells? We wanted to conquer those issues without having to release an entirely new battery. In the end, we found a way to charge our batteries without changing any of the existing circuitry.”

ScreenShot309 Solar Recharger Builds Buzz at TranscendCutting the device down to a manageable footprint was not easy, but Becker reports that they can still do all needed charging in one day. “If we can charge the battery at full capacity for the entire charge time, we can charge a 4-cell in 4 hours and an 8-cell in eight,” he says. “Ideal conditions can’t be expected with a solar panel, so it’s just a starting point. As we enlarge the panel, we really can’t increase that current because it is controlled by the battery. In less ideal conditions, such as clouds in the sky, we can ensure we are getting the highest charge rate possible with a larger number of panels.”

Beyond the nuts and bolts, a marketing strategy has emerged that Becker admits is still evolving. One point to stress is that the solar panels can be used every day, and will last every bit as long as the battery itself.

Somnetics will likely market the item more as an accessory device, and something supplemental to the traditional AC adaptor charge. But for those out camping, fishing, or hiking, it may be the only option. As such, company officials hope to capitalize on this vibrant and growing market.

Plans are in place to exhibit at the APSS (Sleep) show in Boston, an opportunity to show the final product that will likely be available for sale and officially out of the bag just a few weeks later. With so many competitors around, does Becker worry about someone copying the idea? “Those are some of the considerations we will take into account before we do a full release,” admits Becker. “There are some unique things we’re doing in converting a solar current signal to a battery charging signal. That circuitry will be built into our panel and actually riveted onto the device, which makes it something fundamentally different that an over-the-shelf solar panel.”

Accolades and Misconceptions

With no less than two Medtrade awards and the Frost & Sullivan Award for Best Practices earned by Somnetics, company officials have reveled in positive feedback. Becker acknowledges that the relatively small company is now on the radar of the “big boys,” but he insists the attention will not change the way the company operates. “Everybody loves the positive feedback, and it affirms that we are moving in the right direction,” muses Becker. “It is making people realize that Somnetics is going to continue to come out with new products that revolutionize what we’re doing with CPAP therapy.”

Despite the awards, some naysayers persist, and Becker attributes these comments to general misconceptions about solar power. “People think solar will cost too much to be supplemental to an actual CPAP device,” he laments. “We have been able to shrink this device down well enough that we have a price point that is acceptable to the market. Beyond that, it comes down to power capacity. Can a 3-foot by 3-foot solar panel truly charge that battery well enough for me to sleep using this device? Yes, it can be done.”

Headboard Hooks and More

ScreenShot310 Solar Recharger Builds Buzz at TranscendWith the belief that accolades come as a byproduct of hard work, Becker and his engineering team are continuing to tweak the Transcend Solar while also working on a new stand for the device that features an LCD output screen. The screen will give patients the opportunity to review portions of compliance info directly from the system without needing Transcend’s application software for the computer.

An additional extension device will be coming out this fall that will build off the standard Transcend CPAP. “We are going to have new functions in the software and even some new mechanical features to promote patient compliance and DME tracking,” enthuses Becker. “We plan to present it at Medtrade in Atlanta.”

Two other subtle evolutions of the Transcend, including a new filter replacement methodology, are on the horizon. And despite the environmentally friendly solar technology, Becker says the company wants to continue to push the “green” envelope by developing a way to replace filter media in the device without throwing away plastics. “We also plan to offer headboard hooks to hang the device on instead of putting it on the bed stand,” says Becker. “It’s all part of our mission to continue having something to show at least once a quarter.”

“Nobody knew our name when we came out,” adds Becker with a chuckle. “We were the niche product and we were not a threat. Now with these awards over the last 6 months, we are more of a true competitor. Now our customers and our competitors realize we are going to be around for the foreseeable future.”

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