Officials at Somnetics International plans to expand awareness of their product in 2012 while honing in on the cash/retail niche.

In a world where tiny iPods hold thousands of memory-intensive songs, should it be any surprise that a CPAP machine finally weighs less than a pound? Clarence Johnson, president and CEO of Somnetics International, observed the trends over the last decade, and decided to start a mini revolution of his own.

The result is the Transcend Sleep Apnea Therapy Portable CPAP System, a unit that company officials say is the smallest, lightest, and most portable CPAP on the market. “It also has the smallest, lightest, and most portable battery,” says Johnson, who relied on more than 25 years in the biotechnology industry prior to starting Somnetics 3 years ago. “These two things, in combination with the waterless humidification technology, will transform the way CPAP is delivered.”

Somnetics received FDA market clearance for the Transcend obstructive sleep apnea therapy device in July 2010. A little more than a year later, judges at the 2011 Medtrade show in Atlanta gave Transcend the Innovation Award for the product that best exemplifies high tech and state-of-the-art design.

Johnson knows that well-funded marketing departments at manufacturing juggernauts will try to overshadow the positive news, but he’s confident the message will spread. “To compete with the large companies head on would be folly,” says Johnson from his Minneapolis office. “Instead, we believe we have identified a route to market that is unique. Our product is unique, and we think our product strategy can succeed.”

Expanding Awareness
With increased utilization of direct-to-patient marketing, the young company intends to partner with DME and sleep physicians to reach out to the installed base of existing CPAP users. “We also need to market to DMEs and sleep physicians,” adds Johnson. “We want them to know that we intend to partner with them to improve their retail sales with a small and innovative CPAP.”

In addition to the unit’s compact size, judges at Medtrade appreciated the fixed pressure CPAP’s automatic altitude adjustment, good for up to 8,000 feet, with AHI and leak detection reported to compliance software. Tight pressure control at the mask means consistent performance that Johnson maintains is more than suitable for everyday use.

Sleep Doctors who may be unaware of the Transcend, will notice change in 2012. “We should be in sleep labs, but just have not gotten there yet,” adds Johnson. “We exhibit at the sleep meetings, and many sleep docs who attend the meetings have seen the device, and many will soon have an opportunity to try it on patients. One of our great marketing challenges for 2012 is to expand the knowledge of our product within the sleep physician community.”

Cash is King
Officials at Somnetics believe their product is ideal for self dispensing sleep labs looking for a viable cash retail device. Accepting that the Transcend won’t likely be considered as a first-line therapy device any time soon, Johnson believes his product’s niche is currently the growing travel market. “There is a big market for people who buy second CPAPs for travel,” he says. “We believe we can help create a bigger market there with our battery powered unit. For those interested in selling CPAPs for cash, we are a perfect partner. We will help market to your base, and give our customers all the marketing materials they need for free.

“We don’t want DMEs and sleep labs to add our device as a third- or fourth-entry primary device, because it will just sit on the shelf,” continues Johnson. “We think our first and best route to market is through patients who already have and understand CPAPs, and know what features they are looking for. Ultimately, patients will know about the device, and ask for it.”

For DMEs and self-dispensing sleep labs looking for cash sales, Transcend can attract customers looking for secondary travel devices. “Certainly Transcend is reimbursed like other CPAPs, so physicians can send patients to DMEs, and those DMEs can provide this as a primary device,” says Johnson. “And of course, when patients want to travel, they can do it. No other device is that convenient. Every other device is heavier, bulkier, bigger, and creates problems.”

Transcend can be carried and used on a flight, and as a medical device it does not count as a carry-on item. Sleep lab directors and DME providers should advise users to never check a sleep apnea therapy device with baggage because the chances for damage are high. “A doctor can provide a letter stating the user’s diagnosis and the need to carry and use the device on the plane, if necessary,” says Johnson. “Users should call the airline in advance to clarify procedures and in-flight policies.”

For the Medicare and insurance market, the Transcend is reimbursed under the same codes as any other CPAP. The device is not an auto-pap, but instead a fixed pressure CPAP. “We stop recommending at 16 cm of water for pressure,” says Johnson. “For anything above that, we think expiratory relief or Bi-PAP is required. The only thing we don’t have is expiratory relief. Other than that, Transcend is fully featured, and even has more features than some units.”

Waterless Humidification
One crucial feature of the modern CPAP is humidification, and Johnson reiterates that Transcend uses heat moisture exchange technology, which hospital-based respiratory therapists have long relied on for critical care ventilation patients. “We have a great deal of intellectual property developed around the concept of applying this technology to CPAP,” says Johnson, who holds a Master of Science degree in microbiology (biochemistry) from the University of Minnesota.

Somnetics is the first company to offer heat and moisture exchange humidification, a staple for patients on long term ventilation, but not used in CPAP until now. “An insert fits into the breathing circuit and captures exhaled moisture and warmth and returns that to the patient when they inhale with the next breath,” explains Johnson. “It is effective and satisfies humidification needs. When it becomes more widely understood, it will be an attractive option because it is small, easy, and portable. There is no hassle, no mess, and no water. It is a viable alternative to heated humidifiers.”

Somnetics sells its products through an established network of distributors and direct sales representatives serving markets across the U.S., and in key markets around the world. The unit is reimbursable under the standard CPAP HCPC code, and is accepted by most insurance companies.

As the Transcend launch continues, buyers can purchase with a standard 6-ft hose that will work with any mask or seal on the market. Two battery options are available, one with an overnight capacity of 7 to 10 hours at a pressure of 14 cm. “Another option is a multi-night battery that will last 14 to 16 hours minimum at 14 cm,” adds Johnson. “Both batteries work as uninterrupted power supplies for people living in hurricane zones or zones with frequent power outages. Ultimately, we listened to patients in putting this device together, and we feel we have incorporated what they want.”

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For more information about the Transend, visit http://www.mytranscend.com/

At a Glance Transcend’s universal AC power supply automatically converts the power current for international use. Transcend and its accessories and parts are available at medical equipment dealers. Transcend is competitively priced with other CPAP devices on the market. The system comes with a 2-year manufacturer’s warranty. The Transcend Sleep Apnea Therapy Starter System is compatible with any CPAP mask via the Universal Hose Adaptor and standard 6-foot hose. The Transcend H6B and H9M Waterless Humidification Systems come with a proprietary interface that can be fitted with adaptors that are compatible with the most commonly used nasal seals. Automatically compensates therapy pressure to altitudes of up to 8,000 feet. Mobile power adaptor plugs into the DC power outlet in a car, truck, RV, boat, camper or mode of transportation with power. Mobile power adaptor can recharge the Transcend battery pack. P4 Overnight™ battery system provides sufficient power to operate the device for 7 to 9 hours at a pressure setting of 14 cm H2O. The P8 Multi-night™ battery system provides power for 14 to 16 hours of use at the same setting. Both the P4 and P8 batteries are designed to accommodate more than 250 discharge/recharge cycles with standard use. Transcend uses patented heat moisture exchange (HME) technology to provide humidification during therapy. The hygienic heat moisture exchanger (HME) is disposable and has no electric heating elements. HME technology works naturally with the user’s breath to provide humidification. Because it features waterless humidification, Transcend can be placed on the bed, on a pillow, in the bed stand drawer, or on the floor – wherever it’s most convenient. Air bearing blower technology makes Transcend quiet and vibration-free.

Once overlooked as a relatively minor part of the CPAP setup, heated tubes are joining humidifiers as viable ways to recuperate dissatisfied patients.

Are there patients who don’t like the comfort benefits of Hybernite® Rainout Control (ROC) System heated tubes? Johan Verbraecken, MD, concedes that they might be out there, but he has yet to come across any.

As a pulmonologist and medical coordinator at the Belgium-based Sleep Disorders Centre, Verbraecken is all too familiar with the complaints that come with CPAP therapy. Side effects such as rhinitis and a wet face in the morning can derail even the most patient of CPAP users.

Verbraecken, who also serves as e-learning director of the European Respiratory Society, saw this recently in a 5-year CPAP user who happened to work in the security department of a nuclear power plant. The man had successfully used CPAP for 5 years, but started suffering from rainout and/or excessive moisture. “We advised him to sleep with the windows closed, and eventually to warm up the room temperature,” says Verbraecken. “We also offered him a sleeve to protect the tube, but these measures were not effective. He refused to close the windows because he said he could not sleep. He started the Hybernite, and the last time I saw him he was happy with what he called a ‘perfect solution.’ The windows remained open and he was content.”

Meanwhile, physicians may opt to administer nasal corticosteroids to counter some side effects, and humidifiers are always on the docket. When humidifiers alone do not do the trick, Verbraecken does not hesitate to talk about Hybernite, an affordable option, which most people are more than willing to pay. “Every person who has tried the Hybernite heated tubes has liked it—every single one,” he muses.

Why not recommend it right off the bat? Ultimately, Verbraecken prefers to use an incremental approach. “Some patients are happy with the results of the heated humidifier alone,” explains Verbraecken. Despite stellar results with heated tubes, Verbraecken believes most physicians don’t really ponder the negative aspects of CPAP. As a result, knowledge of heated tubing is relatively low.

In some cases, misconceptions may still exist. “When the technology was in development, there were concerns that heated tubes could lead to bacterial contamination and overgrowth, but that is not a problem,” says Verbraecken. “It could be a problem if people use the tube for a long time and do not keep it properly cleaned, but that is also true with non-heated tubes. We would have seen more upper airway infections if concerns were justified, and we have not seen that at all.”

Beyond the physical side effects that can resemble the common cold, unwanted noise is often added to the annoyance list for many CPAP users. Surprisingly, heated tubing can help. “If you have a lot of rainout in the tube, you get a collection of water at the lowest point of the tube,” says Verbraecken. “If you add air, this can lead to bubbling noise which can be irritating. By adding the Hybernite, you can recuperate some patients who may have fallen out of compliance due to this seemingly small annoyance.”

Humble Beginnings
About 2 years ago, a company called Plastiflex Healthcare, a division of Plastiflex Group NV, decided to use its considerable experience manufacturing industrial flexible hoses and apply it to CPAP. Plastiflex contacted Verbraecken’s Centre in an effort to reach the European market.

Plastiflex developed the Hybernite® Rainout Control (ROC) System, which includes the proprietary Hybernite® Heated Breathing Tube (HBT) and Hybernite® Power Supply Unit (PSU). The HBT connects to the PSU via a plug-and-play connector, with copper wires embedded in the tubing wall.

The wires generate heat that maintains air temperature inside the tube, ultimately warding off problematic condensation. Verbraecken notes that the wires are positioned for uniform heating along the tube’s entire length, a system that avoids water droplets on the wall of the tube—and the resulting accumulation of moisture. The combination of the heated tube and the humidifier works to control condensation.

Universal Use
Verbraecken says the Hybernite’s appeal stems from its ability to be used with each kind of humidifier. Other heated tubes on the market can only be used on one machine. “This tube is universal,” says Verbraecken. “That is a major advantage.”

Some manufacturers choose to make tubes that are only compatible with their own machines—a mistake in Verbraecken’s eyes. “Another major heated tube has no independent current, so it gets power from the CPAP machine,” he says. “You can’t combine it with another machine. That is a disadvantage.”

Johan Verbraecken, MD, is a pulmonologist and medical coordinator at the Multidisciplinary Sleep Disorders Centre, Antwerp University Hospital and University of Antwerp. He serves as vice president of the Belgian Association for Sleep Research and Sleep Medicine and e-learning director of the European Respiratory Society.

If you’re living in a fox hole, CPAP is highly inconvenient. Army physicians took this simple truth and turned it into a study that has buoyed the case for adjustable oral appliances.

CPAP compliance can be challenging under ideal conditions. Add the dust, sand, and lack of electricity under combat conditions, and therapy adherence can be virtually impossible.

Major Aaron B. Holley, MD, FACP, ran an ICU unit in Afghanistan for 6 months where he treated combat-related injuries. He saw the harsh Arab landscape firsthand, a place where proper sleep is not a priority. Even in cases of clearly identified sleep apnea, most troops could not afford to give up pack space for CPAP devices and batteries.

Back home at Walter Reed National Military Medical Center (WRNMC), Bethesda, Md, Holley and Lt Col Christopher J. Lettieri, MD, FACP, FCCP, FAASM, continued their work to improve sleep for veterans. They believed that if oral appliances (OAs) were as effective as they were convenient, they could ultimately contribute to a stronger fighting force.

Lettieri, Holley, and additional colleagues attempted to find the answer to this question, ultimately publishing research in the December 2011 issue of CHEST. The study, titled Efficacy of an Adjustable Oral Appliance and Comparison With Continuous Positive Airway Pressure for the Treatment of Obstructive Sleep Apnea Syndrome, confirmed excellent results among mild to moderate sleep apnea sufferers.

Accidents and Explosions
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 combined with sleep apnea can be even worse. “We know that most injuries are not battle related,” says Lettieri, a co-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 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, WRNMC. “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.”

Beyond the obvious benefits of reduced accidents and convenient placement in a ruck sack, 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.”

“When I was over there, we were sleeping next to an air field,” adds Holley. “It’s the nature of deployment that you don’t get a fixed and regular sleep schedule. Even if you take out PTSD and the anxiety of being subjected to mortars and rockets, you still have a situation where people are getting disturbed and fragmented sleep at best.”

Between 2004 and 2006, the Walter Reed sleep clinic gave out oral appliances and CPAP to service men and women on active duty. “When they went to a place without electricity, it would cause problems and sometimes even prevent some people from being able to go overseas,” explains Holley. “The dusty dirty environment made CPAP too difficult to keep clean. Filters in the machines were frequently going down and having problems.”

Large Pool Yields Better Findings
Armed with findings from one of the largest patient populations to date, Army researchers found that adjustable OAs are nearly as effective as CPAP treatment for patients with mild to moderate OSA, and are more effective than fixed oral appliances—particularly in patients with moderate to severe OSA.

“Historically, CPAP has been the primary treatment for OSA, but only half of patients tolerate this therapy,” says Lettieri, an Army medical director, and the chief of Sleep Medicine in the Pulmonary, Critical Care and Sleep Medicine Department at WRNMMC. “This new data offers a fresh look at adjustable oral appliances as an initial treatment for OSA in both the military and civilian sectors.”

The military is interested in the potential of adjustable OAs, also called mandibular advancement devices, as alternatives to CPAP systems since some active duty service members deploy to remote environments where electricity is not always available. In these cases, reliance on CPAP may result in duty restrictions or separation from service. “Adjustable OAs would eliminate duty assignment limitations associated with CPAP, allowing soldiers to travel to remote areas as needed,” adds Lettieri.

The study in CHEST evaluated and compared results of overnight sleep studies in which patients used adjustable OAs or CPAP devices. 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, compared to past reports (62.3% versus 54%).

In most research trials of oral appliances, patients receive oral appliances after they have already failed with CPAP.  It amounts to a selection bias because patients have already failed, and researchers often never really know why they failed. “We thought our data set was unique because a fair proportion of our patients did not fail CPAP since they were given both at the same time,” explains Holley. “The problem with doing this in the real world is you run into cost limitations. It is not cheap to do either of these therapies individually, never mind giving both to everyone up front. This is true in the military or civilian world.”

Changing Perceptions
Holley contends that physician “CPAP followers” are fairly devoted, tending to favor the humidification features of the modality. “Some docs are comfortable with what they are comfortable with, regardless of the evidence, even when it is compelling,” laments Holley. “It takes time to change people’s minds. How much will change with this study is hard to say. I would hope we have at least shifted the thought process and debate so that pulmonologists like me are more likely to not automatically go to CPAP for mild to moderate. It really does work just about as well as CPAP for people who have mild to moderate disease.”

Lettieri and Holley believe the study will (and should) contribute to a shift toward considering OAs earlier in the patient experience. More comparisons with CPAP are necessary, but Holley admits it can be difficult to level the playing field. “CPAP is electronic with a smart card that records compliance,” he says. “We know exactly how well it’s working. The struggle with studying oral appliances is that you must rely on self reporting from patients as to how much they use it. We can prove that oral appliances work, but the next thing to prove is if patients actually wear them more than CPAP. We suspect they do, but we have yet to prove it.”

Building the case is something that Lettieri is content to do. As a 40-year-old physician in a relatively young field, he has seen awareness grow exponentially, and he has helped the military change its perceptions. At Walter Reed, the size of the sleep lab has doubled in recent years and the staff has tripled. Consults have gone from 70 per month to often 70 in a day.

In a culture where sleep deprivation is part of the culture, Lettieri admits that raising awareness has not always been easy. “When I enlisted, the recruiting slogan was ‘We do more by 9:00 a.m. than most people do all day,’” he muses. “We get up early and operate at night. There is a sleep-when-you-can mentality. Americans as a whole keep shortening their average sleep time at night. Since the 1970s, we have about 1.3 hours less per night. The military is even worse.”

SIDEBAR: Military Intelligence
As program director of the Sleep Medicine Fellowship at Walter Reed National Medical Center, Bethesda, Md, Lt Col Christopher J. Lettieri, MD, FACP, FCCP, FAASM, has seen the evolution of sleep medicine. In a culture where sleep deprivation is often considered a badge of honor, the 40-year-old Lettieri has succeeded by educating top brass and soldiers alike with a powerful message: Well-rested soldiers are more effective in the field of battle.

Nowadays, the sleep lab at Walter Reed is a full-fledged sleep disorders center that is recognized as a center of excellence. In addition to pulmonologists, neurologists, pediatricians, and even psychiatrists are applying for fellowship training. Sleep Diagnosis & Therapy sat down with Lettieri to talk about the explosion in sleep awareness and the implications for the military.

How tough is it to get proper rest in the military?
Lettieri: If you are talking about deployment, your sleep quality gets worse because you go from the relatively quiet environment to sleeping among a bunch of other people. There is more noise, radios, helicopters, explosions, and the constant stress.

Is sleep apnea more or less common in the military population?
Lettieri: Sleep apnea is common in general, and it’s common in the military. Even though we tend to be younger and more physically fit, we still have a lot of sleep apnea.

Why is that?
Lettieri: Some of it is anatomic, but a lot of it has to do with chronic low level sleep deprivation. You lose your ability to maintain tone of your upper airways. Back when I was a fellow, I did a research study called, “Obstructive Sleep Apnea Syndrome: Are We Missing an At Risk Population.” Across America, most people thought about sleep apnea in the 55 year-old overweight guy snoring in your waiting room. But really you see it in younger, thinner people. And if you don’t think about it, you’re going to miss the diagnosis.

Are physicians outside of the sleep realm starting to think about sleep apnea outside of the stereotypical patient categories?
Lettieri: With some of my prior research, and in a lot of the lectures I do now, I am trying to get people to think about it in the less typical person, such as the younger girl with chronic headaches and depression. Or the young guy who has unexplained fatigue and ADHD. I’ve always thought we had a lot of it in the military because of this chronic low level sleep deprivation.

Are there examples among fit combat soldiers?
Lettieri: We have had young, active duty guys who get diagnosed with sleep apnea. If it is toward the earlier part of the war, what do you do with them? You cannot bring CPAP in the theater with you. If you’re living in a fox hole, where are you going to plug it in?

Are CPAPs possible at the larger bases?
Lettieri: Even with the more mature theaters we have now, where everybody has laptops plugged in and lamps, you still can’t plug in a CPAP. The Central Command that runs the war said you can’t bring it.

So what do you do now? You’ve got a young guy, and if you tell him he has sleep apnea, he may be out of a job. The alternative is oral appliances.

When did oral appliances emerge as a viable alternative?
Lettieri: A couple of years ago, when we started this, oral appliances were largely considered an alternative to CPAP. You could consider oral appliances if they had a really mild disease, or really hated CPAP.

What do you with young guys who have severe disease?
Lettieri: You can’t say, ‘Well you’re out of the army.’ So we pushed the envelope way beyond what was accepted, because we didn’t want anyone to be forced out of the Military because of sleep apnea” At one point, we had more experience with oral appliances than most of the country combined. We had to get this message out, so we published two papers almost back to back.

Why did you focus so much on the oral appliances?
Lettieri: We did it largely to conserve the military fighting strength. On one hand, we want to find alternatives to CPAP, because while it is great, lots of people don’t like it.

Across the country, it’s a constant battle with better adherence. You can say that with all medical care, but the difference with CPAP is it has an integrated compliance monitoring device. So we look at this thing and we can tell exactly when the person used it. Some people abandon therapy, and roughly only half of people on CPAP have regular use of their therapy. That’s terrible.

CPAP may be great, but if people aren’t going to use it, we’ve got to have another treatment option. For us on a more personal note, we also have to maintain the fighting strength. We must be able to send people into combat.

You don’t diagnose sleep apnea, and then let soldiers go out with an untreated medical disorder. That is not good for anybody. In that case, you are taking very sleepy people and putting them in harm’s way, and you’re going to see more accidents.

How effective are oral appliances?
Lettieri: Nothing’s perfect by any means, but even half of the people with severe disease got what we considered to be adequate therapy. It depends on where you draw your line in the sand.

“We use strict criteria for what we consider to be effective therapy.  It would be hard to argue with this criteria, so most people would have to agree that adjustable oral appliances work.” If we realize that only half the people are actually using their CPAP anyway, then you’re no worse off. Even if CPAP were completely effective, half the people are not going to use it.

What do you think of non adjustable or fixed devices?
Lettieri: The problem is that you get one shot to fix them. We found that they are OK, but only for really mild disease. Anyone with moderate to severe, you need adjustable. And these are ones you can titrate, just like you do when adding a higher dose of a medication or a range of pressures with CPAP. Adjustable ones ought to be used, and are probably more cost effective in the long term because more people get adequate therapy.

What do you think of tongue control devices?
Lettieri: These are essentially suction bulbs affixed to your tongue that pulls your tongue forward. They really don’t work well—maybe for very mild disease they can be adequate. Most patients find them uncomfortable and they are not used much in clinical practice.