With help from Ann Halbower MD, of the Pulmonary Department at Children’s Hospital Colorado, Aurora, CO, the mission to serve the smallest sleep apnea patients with CPAP masks is gaining momentum.

Marketing new CPAP units to a burgeoning adult patient population takes a lot of time, money, and energy. In this highly competitive environment, it’s no wonder that pediatric devices have received relatively short shrift over the last decade.

Not all manufacturers, however, have ignored the “small” market. California-based ResMed got the ball rolling 7 years ago with its Mirage Kidsta mask, a unit cleared by the FDA for children 7 years of age or more than 40 pounds.

Based on the Mirage platform, the Kidsta combined dual- wall cushion technology in an attempt to fashion a comfortable mask for smaller faces. In 2010, the Mirage Micro for Kids took the technology yet another step forward. From there, the evolution has continued thanks to advocates such as Ann Hal- bower, MD.

With passion and knowledge built up over more than two decades as a board certified physician in pediatric pulmonology and sleep medicine, Halbower has made her voice heard even in the halls of Congress. “I have screamed about this for 20 years,” says Halbower, an associate professor of pediatrics in the Children’s Hospital Colorado Sleep Center, affiliated with the University of Colorado, Denver School of Medicine. “I worked with the American Academy of Pediatrics to develop and push for the Pediatric Medical Device Safety and Improvement Act of 2007, and that bill was passed for us to improve and facilitate development of pediatric medical devices.”

Since then, the FDA has approved CPAP usage for children as young as two years. Working with many sources to help these younger kids under the FDA ruling, engineers at ResMed developed a new mask. Recently launched, the Pixi pediatric mask is designed from the ground up specifically for kids, and is not simply a “sized down” adult mask.

Meeting an Unmet Need

Officials at ResMed believe it is important to address the unmet needs of the pediatric population. “With our pediatric line, our goal is to provide a solution for a group that is often neglected,” says Bernadette McBrearty, Vice President – SDB SBU at ResMed. “We pride ourselves on taking in market feedback to develop products that meet people’s needs while providing viable long-term solutions. Our pediatrics line is part of that.”

Despite widespread perception in the industry that pediatrics is not a lucrative market, Halbower is convinced that investment in pediatrics makes good clinical and financial sense. In a wide-ranging conversation with Sleep Diagnosis & Therapy, she expressed enthusiasm for ResMed’s commitment while making an impassioned plea for more pediatric sleep apnea awareness in the medical community.

Are you pleased with the FDA’s level of awareness when it comes to devices that treat pediatric sleep apnea?

Ann Halbower, MD, associate professor of pediatrics, University of Colorado, and Director of Pediatric Sleep Research at the Children’s Hospital Colorado Sleep Center: We still do not have approval for kids younger than two. That is a huge problem, because that is where I see the largest unmet need.

Why did you lobby for the Pediatric Medical Device Safety and Improvement Act of 2007?

We found that there were too many children using devices off label, or using adult devices that were not made for, or studied with, children’s safety and efficacy in mind. I have been working since 2004 directly on trying to improve the availability of medical devices, specifically for sleep apnea in kids.

I have been working with device companies, the American Academy of pediatrics, and I worked with the American Thoracic Society to develop the legislation. For me, it seems a very slow process. We know that these devices are available overseas, but they are not as available in the United States.

It costs too much for premarket approval in the United States for companies to consider going through the FDA process. I am very happy that ResMed has agreed to develop some of these devices for smaller people. There is a huge market, and a huge unmet need in children who are infants to toddlers. We have zero devices available for them that are FDA approved for home use. I think that device companies would be very surprised at how often those devices would be used if they were available. Infants and toddlers often just need a device to get them by until they grow out of a problem.

How would you characterize the current awareness of pediatric sleep apnea among general practitioners and the public in general?

Unfortunately, pediatric obstructive sleep apnea is really a public health problem that is unrecognized. We know that 10% to 16% of children will habitually snore. Out of a population of children, at least 2% to 3% have frank apnea.

What is the level of awareness among fellow pediatricians?

Most pediatricians still do not screen for who is snoring and who is not. We still get many children who have had problems and symptoms for many years, but it has gone unrecognized, unchecked, and undiagnosed. It is not until new providers or teachers pick up on the fact that a child is very sleepy or is behaving abnormally.

Are surgical remedies working?

A lot of ENTs get kids with snoring or big tonsils and they operate on them, but there is another unrecognized problem. Adenotonsillectomies really only cure about 50% of all comers when it comes to childhood sleep apnea.

Fifty percent not cured is a large number. How can we make sure these kids don’t fall through the cracks?

We used to think that surgery would cure 90%, but so many kids have craniofacial abnormalities or concurrent asthma and allergies, obesity, and all of these things that play a role as to whether you are actually cured at the end of surgery. Almost everybody gets better, but getting all the way down to an AHI of less than one is hard to do.

Are manufacturers doing enough to address the pediatric market?

Device companies have not run with the ball to use that legislative act to enter into markets that still have huge, unmet needs and gaps. Sleep apnea in kids is unrecognized, not screened for, and it is a public health problem because it causes so many other secondary problems. Kids who have sleep apnea generate two and a half times more in health care costs. They tend to have cognitive issues, cardiovascular risk, and they often have superimposed obesity. This can affect their school performance, which can affect their entire economic output in life.

I am putting in my two cents to say that it may look like a small market, but the market is actually pretty huge in the United States. For the new device by ResMed, we tried it on a lot of tiny heads and we found that several tweaks were necessary. I think users will find them helpful, including having the tube come off from the side so it does not obstruct vision. We have very little dead space around the nose so pressure can be delivered without CO2 retention.

How early should we treat sleep apnea?

We need to recognize sleep apnea and treat it early, even in infants. It is my hope that device companies will help us with that by entering into markets where we do not have devices available.

Why don’t pediatricians screen more often for sleep apnea?

I do not think pediatricians recognize the long-term consequences of not treating sleep apnea. We do our best to train doctors in this, but busy health care providers have 10 minutes to see somebody, and they are trying to get through immunizations, car seat safety, and other concerns. We must remember to screen for snoring, because parents do not often say to doctors, ‘My kid is snoring and I think he has a sleep disorder.’ Parents do not recognize it as a problem, especially if it has been there a long time. Unless you screen for, it is not going to be picked up.

Other than snoring, what are the different signs of sleep apnea in children?

Gasping, gagging, and labor are more common, but discrete signs of apnea in children are not easy to recognize,. Children can have prolonged partial obstruction. They can continue breathing without waking up, but they may be working hard to breathe, while having gas exchange abnormalities.

Kids can have an adult-like phenotype, but they do not always. The younger the child, the more different are the symptoms. If infants have apnea, they may make no noise at all. For those who have a long epiglottis that is almost touching the soft palate, their apnea is silent. Or they may have stridor. Some children have very large tonsils and adenoids, but sometimes those tonsils and adenoids are so large that they prevent the vibration of snoring.

What are the therapies for severe apnea in infants?

In the United States, our only approved therapy for severe apnea in infants is tracheostomy, and that is a huge burden and a huge health care cost. Families do not have enough home nursing to send these kids home right away. It increases our medical costs enormously, not to mention the morbidity and mortality of kids.

How difficult is it for kids to adjust to CPAP treatment?

They certainly have different issues than adults. First of all, we have all learned that CPAP does not work in children unless the parents have bought into it. It is a teaching program that is required, because you must get the parents to learn why it is important and why it is important to be consistent with the child.

In my sleep program alone, we have more than 520 children on noninvasive ventilation. A clinical psychologist and dedicated respiratory therapist helps to desensitize children to the masks and teach parents appropriate clinical introductory skills for the children. Once again, buy-in from both parents and a lack of fear from the children means more success.

We have more success with little kids, especially special needs kids, then we do with the older teenagers who by now have decided whether they are or are not going to use it. Of course, there are fewer issues that around body image in younger children that can conflict with adherence. It is not easy to sleep with a device on the nose every night, but we find that our compliance is improved if we use a slow introductory process and we actually get the parents to help us with age-appropriate introductory skills.

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Ann Halbower, MD, is an associate professor of pediatrics at the University of Colorado. She also serves as director of Pediatric Sleep Research at the Children’s Hospital Colorado Sleep Center, Aurora, Colo. For more information, visit www.childrenscolorado.org/conditions/sleep/

With newly published clinical research, Provent Therapy offers physicians and patients another choice beyond CPAP, oral appliances, and surgery.

More than 2 years after bringing Provent Therapy to market, Rajiv Doshi, MD, continues his quest to educate patients and sleep doctors about the benefits of expiratory positive airway pressure (EPAP). Considering that obstructive sleep apnea is generally thought of as an inspiratory process, this has not always been an easy task.

Despite the challenges, Doshi and a dedicated team at Belmont, Calif-based Ventus Medical (makers of Provent Therapy, www.proventtherapy.com) have meticulously built their case on a foundation of clinical research, patient choice, and business opportunity for sleep physicians and sleep laboratories. To date, there have been seven published studies attesting to the clinical efficacy of Provent Therapy.

The most influential of the studies, involving 19 centers, 250 subjects, and a 3-month follow-up, appeared in the April 2011 journal Sleep. “In this study, roughly half the people were in a sham arm and the other half in the active Provent arm,” explains Doshi, a consulting assistant professor of Medicine at Stanford University, Palo Alto. “The study showed dramatic and statis tically significant improvements in AHI for the active arm, but not in the sham arm. This benefit was maintained for the full 3 months of the study. At the same time, the Provent arm showed significant improvement on the Epworth sleepiness scale and high compliance rates.”

Doshi predicts the study will serve as the defining nasal EPAP study for years to come, with awareness only building among patients and physicians who crave choices beyond CPAP, oral appliances, and surgery. Provent’s unobtrusive two devices (that adhere to each nostril) attracted a standing-room-only audience at this year’s APSS conference, a testament to burgeoning interest that will only grow as the massive undiagnosed and CPAP non-compliant populations seek more options.

Counter Intuitive

Rigorous clinical studies conducted by highly respected sleep physicians are making it easier to spread knowledge about the admittedly “counter intuitive” technology that fuels Provent Therapy. Many physicians, for example, wonder how an expiratory device can help treat what is commonly known as an inspiratory condition. “When you inhale, the valve opens for normal breathing,” explains Doshi, who also serves as the United States executive director of Stanford-India Biodesign. “When you exhale, the valve partially closes, and in the process it creates a resistance. This resistance generates expiratory positive airway pressure, and that provides a little bit of pressure into the airway right when the airway is most prone to narrowing and collapse—which is at the end of expiration. Because the airway is more open at the end of expiration, it is believed it is less likely to collapse on the next inspiratory effort. It is a little bit counter-intuitive.”

For ongoing use, patients can buy packs of 30 (a 10-night trial pack is also available), using each pair for one night, and then throwing them away after use. The device uses a Micro- Valve design that attaches over the nostrils, secured in place with hypoallergenic adhesive. Doshi hopes physicians will understand that beneath the simplicity lies a validated and emerging body of clinical data that they can rely on and confidently offer to patients.

Whether sleep doctors refer to others (such as HME companies or sleep labs) or choose to self dispense, the opportunity to build the practice stems from the crucial element of choice. If patients know that a less intimidating choice exists, they may be more motivated to stick with the process from start to finish. “From the time they are told they have a problem to the time they can get therapy, there are a lot of chances to lose motivation,” says Peter Wyles, president and CEO, Ventus Medical. “If patients are aware of other options, they may be more inclined to speak with the sleep specialist and get a sleep test than if CPAP were the only option. If sleep doctors can’t convince patients they will be successful with CPAP, they can talk about Provent as a second-line option.”

Expanding the Lingo

How big is the acronym awareness challenge? Googling “CPAP” yields about 6.4 million hits, and virtually all selections refer to continuous positive airway pressure. Meanwhile, a search for “EPAP” garners slightly more than 400,000 links. That wouldn’t be so bad, but 99% of those refer to countless other acronyms, such as the Egyptian Pollution Abatement Project, that have nothing to do with sleep medicine.

Doshi is not surprised that awareness has a ways to go. While he learned about sleep apnea during his education at Stanford Medical School, the specialized knowledge he has today has largely grown out of his own interest in the physiology of sleep. This knowledge led him to conceive of a solution to tackle sleep apnea through the expiratory process about 7 years ago. With intellectual property safeguards in place, the idea continues to gain ground in an industry largely dominated by large CPAP manufacturers with sizable marketing budgets.

Friendly Competition

It may seem daunting to introduce something new, but Wyles and Doshi believe that positive outcomes and a patient-first philosophy will steadily build the business. Instead of going head to head with CPAP, Doshi is confident that Provent can peacefully coexist. “We are not trying to be competitive with CPAP. CPAP is an extraordinary therapy and life changing for many patients,” he says. “We view Provent as an alternative that gives physicians the opportunity to focus on those who are not being treated with CPAP. I don’t think the CPAP companies are viewing us as a competitor. We have a friendly relationship with these companies. In fact, we think Provent will bring many new patients in to be diagnosed and will bring non-compliant CPAP patients back into the system as well.”

By most estimates, the pie is growing, with 75% of sufferers still undiagnosed. Doshi points to a presentation at the 2010 APSS conference that estimates about 90% of people who have given up on CPAP are looking for other treatment options. “Those options could be surgery or oral appliances,” he says. “However, patients prefer things that are non invasive, and Provent would be a leading candidate in that realm. Right now, there is a treatment dilemma for docs, because CPAP may be overkill for some patients, including those with less severe OSA and without comorbidities.”

According to Philip Westbrook, MD, the whole point is to offer something that patients will actually use. “The gold standard of treatment is CPAP,” says Westbrook, who serves as chief medical officer for Ventus Medical. “But too many patients do not use it, or do not use it adequately. There is a huge pool of patients already diagnosed, and undiagnosed, and they need treatment. Too many of those folks just do not get any treatment at all. Here we have something that is simple to use, inexpensive to try, and if it works and they use it, it will be terrific.”

Stats Don’t Lie, Right?

Industry experts agree that statistics point firmly to solid economics for the sleep industry. But despite the numbers, a rough economy can put sleep apnea on the back burner with patients viewing it as a tolerable ailment. Add on the undeniable concerns about CPAP, and Provent officials believe that viable options are needed to bring more people into the fold who may have stayed away.

HME companies and self dispensing labs are feeling the financial strain due to many factors, and Wyles believes they are thirsting for something new. “When you talk to sleep lab officials who say they can’t fill their beds, it’s an amazing comment when you consider how many people are out there suffering,” says Wyles. “It’s true that suppliers are getting squeezed by the government. Competitive bidding whacked them by 30%, and everybody in the supply chain is getting hammered. It is sad for the docs who want to treat patients. Even with these economic issues, boosting patient motivation to get diagnosed, treated, and stay compliant can be accomplished.”

Far from shunning the cash aspect, Doshi believes patients will readily embrace the upfront money concept primarily because Provent is markedly less expensive than other options. “It’s so easy to try that it will certainly be a second-line option that is much more acceptable than surgery,” he adds. “The same would apply to oral appliances. If you are going to get a custom oral appliance made, you need to go to the dentist, and then get follow-up care to make sure there are no adverse events. With Provent, patients can try the device for a nominal up front cost—far less than oral appliances. Economically, Provent should become the dominant second-line therapy quite quickly, and we are seeing that. It could also be a great first-line option, especially in the mild to moderate group without comorbidities. Many physicians believe that CPAP and Provent will be the dominant treatment options of the future.”

Expanding the Possibilities

One subset of the sleep disordered population is a group already using CPAP, but even for these devoted patients the bulky machine is not always convenient. “Many people decide not to bring their CPAP when they travel,” says Doshi. “They don’t’ want the hassle of taking a CPAP machine through airport security. For those occasions where they are traveling, camping, or during a power outage, Provent represents an opportunity to provide patients and physicians with another therapeutic option.”

Westbrook is equally confident that Provent can fill these gaps. However, he also points out that like all other sleep therapies, Provent is not for everyone. “We know that not all patients will use or benefit from Provent,” concedes Westbrook. “We can’t a priori reliably pick out those who successfully use Provent, but it doesn’t make much difference because we can inexpensively and accurately find out whether a patient will use it, and whether or not it works. While right now, we can’t accurately predict the people for whom it won’t work, we are not too much different from other therapies such as oral appliances and surgery. Even with CPAP, we can’t really predict who’s going to use it and who is not going to use it.”

A Competitive Edge

Whether it’s in spite of or because of politicians, the historically resilient American economy seems to always make a comeback. If this comeback coincides with a realization of the sleep apnea patient potential, consultants agree that it’s wise to prepare now and establish trust and referral bases. “The Provent device, which was cleared by the FDA in 2008 for the treatment of OSA, works differently in different people,” says Doshi. “Some may get a huge AHI reduction, and some may not. It is important to test whether the device works, and the ideal means to confirm this is an in-lab PSG or a portable study.”

According to Wyles, “With all the proper pieces in place, this is a solid clinical practice builder. For the subset of docs and sleep labs that are dispensing, they can realize the annuity on the sale of Provent as well.”

Ultimately, patients want selection, and general practitioners want to send their patients to sleep doctors who get results. “With Provent, physicians are able to market themselves as clinicians who prescribe new and cutting-edge therapies,” adds Wyles. “With more clinically validated options, it shows they are among the leading sleep doctors and enhances their reputation, which drives more referrals, and most importantly leads to healthy and satisfied patients.”

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For more information visit www.proventtherapy.com

Rajiv Doshi, MD, invented the core technology and founded Ventus Medical. Rajiv is a Consulting Assistant Professor of Medicine and a Lecturer of Mechanical Engineering at Stanford University. He is the inventor on over 30 pending and issued patents. Rajiv earned a BS in Chemical Engineering, an MSE in Biomechanical Engineering and an MD from Stanford University.

Peter Wyles, President and CEO.
Peter joined Ventus Medical as President and CEO in June 2010. Peter was most recently with Bayer Healthcare for 15 years where he led consumer, pharmaceutical and medical device businesses in Germany, Japan, Canada and the U.S. He also led the global expansion and integration of Metrika, a former start-up in the diabetes space that was acquired by Bayer HealthCare in 2006.

As a pioneer in dental sleep medicine, Steven R. Olmos, DDS, sees a profession beyond traditional boundaries, with oral appliance/CPAP combination therapy as an increasingly viable option.

Steven R. Olmos, DDS, does not believe a weekend course is enough to prepare a dentist for a career treating sleep disorders. However, the 2008 recipient of the American Academy of Craniofacial Pain’s (AACP) Haden-Stack Award for contributions to the field of TMD and craniofacial pain does believe it can be a great way to start.

For dentists who have the drive and curiosity to fully explore sleep disorders, Olmos contends that patient potential is enormous. As a career path, many go a step further and argue that the future of dentistry lies squarely in the realm beyond traditional restorative practices. “If dentists don’t turn into dental physicians, they are going to be obsolete if all they can do is mill teeth,” says Olmos, founder of TMJ & Sleep Therapy Centres in America and abroad. “My life’s mission was to get these philosophies into a dental school, and that has already happened for the last 7 years.”

In conjunction with his La Mesa, Calif-based TMJ & Sleep Therapy Research Group, Olmos now offers courses to prepare dentists for AASM-affiliated accreditations from the Academy of Dental Sleep Medicine (ADSM). These diplomate designations and board certifications are desired by many dentists, but precious little training is out there. “I produced what I call a mini residency in craniofacial pain and sleep,” says Olmos. “The reason I did this a dozen years ago is that when I took all the proper examinations, I found there were no preparatory courses. I did not want others in the same boat.”

The AACP has since developed its own mini residency for sleep in combination with Tufts University. “We are finally moving in the direction where there are places for dentists to go to get educated,” enthuses Olmos. “It really should be in the dental schools, and students should be taught this at the undergraduate level, and not at the postgraduate level.”

Olmos’ mini residency starts with an introductory component in the classroom setting, with a total of three sessions in 2 days. From there, students are encouraged to take a hands-on course which is dubbed the advanced residency. This six-visit, 2-day course is a place to apply lessons on actual patients. “At the completion of that,” says Olmos, “I have comfort that people really understand the didactic component and how to deliver appliances, how to make adjustments, and how to work with physicians for optimal care.”

Courses at Tufts and the University of Tennessee (where Olmos serves as an adjunct professor) are in this vein, but they are few and far between around the rest of the country. Why the lack of programs? Ultimately, they are difficult to organize, and cultural change within medicine can be agonizingly slow.

Yet another boundary to widespread education is fear of violating the health care practitioners vow to first do no harm. “Often the biggest concern for dentists getting started in sleep medicine is causing jaw joint problems,” says Olmos. “It’s impossible to separate craniofacial pain from sleep disorders be cause of the high prevalence of overlap. Most people who have jaw joint problems—that were not hit by a baseball bat—usually have a breathing problem. Grinding teeth is usually about maintaining an airway and moving the jaw forward. Dentists are concerned because they know that if they put things in people’s mouths they may make jaw problems worse.”

Even the seemingly innocuous night guards are now, according to some studies, causing people with apnea to get 50% worse. “You can’t separate people with jaw problems from people with breathing problems,” says Olmos. “They are the same people.”

Acceptance High, Awareness Still Low

Among health care practitioners in general, awareness of sleep disorders is relatively low, primarily because they have not been trained. Olmos estimates that most physicians are still treating comorbidities, such as hypertension and cardiovascular disease, as a separate problem.

Even if these physicians got a report about apnea, they would likely refer out to a DME provider, automatically placing CPAP as the only solution, or perhaps CPAP in combination with surgery. The last thought, if ever, is an oral appliance.

Literature increasingly shows that people prefer oral appliances, and Olmos sees a world in the not too distant future where it is not an either/or proposition. “Oral appliances may not be as efficacious as CPAP, but in my opinion it is never all or none,” he explains. “I have CPAP patients with horrible jaw problems who need an appliance and CPAP. It’s about finding the optimal treatment for each patient. Combining treatments can be optimal. Physicians are more open to that.

“There are people who simply can’t tolerate CPAP, and there must be alternatives for them,” Olmos continues. “Combinations of therapies certainly are indicated, and that should be the prime thought process. What is best for the patient given the circumstances?”

In a world in which 90% of people with sleep disorders have not been diagnosed, more options may not only be desirable, but ultimately essential. “We may all be overwhelmed someday,” muses Olmos. “Modified CPAP therapy, in conjunction with oral appliances, may become essential to the equation.”

Education, not vilification, will ultimately resonate with health care providers. “Sometimes wedges are put in by dentists who encourage hate toward CPAP, which angers physicians and polarizes,” laments Olmos. “We should be working together for the best result. There is enough for everyone. We are in our relevant infancy at 50 years. Sleep disorders will end up being one of the biggest parts of medicine, because breathing is the highest priority. You can survive almost a month without eating, but how long without breathing?”

A Plan to Get There

In conjunction with his La Mesa, Calif-based TMJ & Sleep Therapy Research Group (www.tmjtherapycentre.com), Olmos offers courses and TMNDX software to foster a systematic data intake for all new patients. Developed from a need to educate, the software and courses are based on the premise that the role of sleep in above-the-shoulder pain must always be thoughtfully considered.

A complete understanding of jaw joint problems must ultimately view the jaw joint as more than a mechanical problem of displacement. “At first, we said the jaw just needed to be relocated and maintained, but the driving mechanism is what happens when you are asleep,” says Olmos. “Macro trauma is easily explained, and can be treated surgically. It is all the other cases of jaw joint pain, which are the majority of cases. Most times it is because of micro trauma caused by the repetitiveness of low threshold energy to the system.”

The intake information looks at different physiological structures and walks dentists through the formulations and thought processes of how to identify, and then make, a diagnosis. “The problem in dentistry is that we are so quick to do a treatment, we never make a diagnosis,” explains Olmos. “We try an appliance or treatment, but we don’t know what we are treating, and that is the problem. The software helps develop a diagnosis, and then it asks you after you have a diagnosis, ‘What kind of a plan do you have? What are your goals?’ You have to have goals before you have a plan.”

Different plans for different problems guide the thinking behind the software, which is also useful for orthodontics. “This is truly an interdisciplinary approach,” adds Olmos. “As part of the software, we make it clear that other health care professionals will need to be brought into the system to make a person better. No dentist, or any one person in any type of profession can help people in chronic pain—because if you have had chronic pain in one area then you’re going to have pains in other areas. These other areas may be out of the specialty of whatever provider is taking care of you.”

Olmos’ comprehensive system of triage could someday be the standard of care that all dentists use. “It is certainly what I am teaching at the University of Tennessee where I am an adjunct professor,” says Olmos. “I am working with the American Academy of Craniofacial Pain and the University of Tennessee to produce a craniofacial pain and sleep clinic at the University, and it would be using these techniques from the software, and make that the standard of care for all the patients that are going through that program.”

Clinicians interested in the software can download it at www.tmndx.com. In the works for the last 6 years and introduced 3 years ago, the system bills medical insurance, gathers input into a letter writing program, and generates communication letters to other practitioners and insurance companies. “We use it at our centers and have about a hundred who are using it now,” says Olmos. “It’s a great tool, but right now only specialists know about it. I’d like to see more dentists doing this kind of basic triage.”

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Steven Olmos DDS has been in private practice for over 27 years with the last 18 years devoted to the treatment of TMD, Orofacial Pain and Sleep Disordered Breathing. He is the founder of TMJ & Sleep Therapy Centre International, with licensed Centres located in the U.S., Canada and New Zealand (http://tmjtherapycentre.com/)

Sleep physicians who refer to dentists want to know that patients can choose based on experience of the dentist, number of appliances offered and levels of fees.

When it comes to dental sleep medicine, sleep physicians tend to be concerned about the same things. Oral appliances are not covered by insurance (they believe), they are too expensive, and patients don’t come back for objective follow-up.

Jamison R. Spencer, DMD, MS, often hears these complaints during his many lectures across America. He even heard it across the Pacific during a recent presentation in Australia.

No matter where they happen to be, sleep docs want more treatment options for patients. Spencer, who heads the Craniofacial Pain Center of Idaho and Colorado, with locations in Boise and Denver, says referring physicians are looking to refer to dentists who not only offer the more expensive, custom appliances, but who have less expensive options available too.

Some sleep docs, however, don’t seem to understand that often you get what you pay for. “Medical doctors often look for whoever is cheapest, and they assume that any dentist who says he can make an appliance knows what he is doing,” said Spencer, an adjunct faculty member at Tufts University Dental School. “Just last weekend at Tufts, a physician commented that there was no evidence to prove that a $3,000 appliance is any better than a $1,500 appliance. That is absolutely true. Where there is a difference is between dentists who do a more comprehensive evaluation, provide multiple therapy options, have excellent follow-up and know how to handle potential side effects such as jaw and TMJ pain.”

As a diplomate of the American Board of Dental Sleep Medicine and the American Board of Craniofacial Pain, Spencer and like- minded colleagues have spent more than a decade refining the skills and nuances of dental sleep medicine. Physicians generally appreciate the distinction of specialization in other realms, but that is not always the case when it comes to dental sleep medicine.

Dentists who merely offer dental sleep medicine as one of their many services may not have the expertise. “It is up to us to show through outcomes that we can get better results by knowing what we are doing,” says Spencer, who invented an oral appliance called The Silent Sleep, which is offered by Cadwell Therapeutics. “All of the art and science must come together to provide the best outcomes.”

Spencer’s low-cost Silent Sleep is one option that can serve as a temporary bridge to a more permanent solution. For those who can’t afford fully custom oral appliances, it can also be used as a long-term device under the guidance of a knowledgeable dentist.

The Silent Sleep costs the dentist under $100, and takes 10 to 15 minutes to fit—not including examination. “Patients can try it and see if they can tolerate an oral appliance,” says Spencer. “We have a model where they use a temporary appliance, go back to a sleep lab, and see if the appliance is working. We can try three different jaw positions to determine which is most effective. From there, we have spent little money, determined they can tolerate an oral appliance, and confirmed it is helping. Referrals will typically increase because the medical doctors feel more comfortable referring when they know the dentist has options for the patient.”

Dentists who devote the vast majority of their practice to dental sleep medicine are admittedly rare, perhaps two or three dozen in the entire country. Should the lack of specialists hinder the spread of the technology? Spencer believes that is not necessary, and many patients can still be helped.

Better Than Nothing?

With so many people who need relief, Spencer contends that the perfect should not get in the way of the good. “Some say dentists should not be doing any of this unless they get properly trained and educated,” says Spencer. “On the other hand, you have patients who have given up on CPAP. Every night they may be getting closer to a heart attack or stroke. Isn’t it better to try something that may yield a positive effect? This is why we have over-the-counter drugs. Sometimes something is better than nothing.”

However, Spencer cautions that sometimes dentists may unintentionally do harm. After all, he says, dentists already treat sleep and breathing without really knowing it.

A Canadian researcher did a small scale study that showed AHI worsened in some patients when using a night guard that dentists typically fit to protect a patient’s teeth from grinding. Dentists don’t intend to treat breathing problems with night guards, but Spencer says that in many cases they are inadvertently making some people worse. He hopes that more and more dentists will start screening their patients for sleep apnea and refer them for proper medical evaluation.

Spencer uses such a screening tool in his practices, incorporating the Epworth sleepiness scale, the STOP BANG and a few questions regarding clenching and grinding. “In three cities now, we have given out that form to general dental offices,” says Spencer. We ask that they give it to everyone who walks in the door, regardless of age. We find that 20% to 30% of people who walk through the door of these offices likely have sleep apnea, or bruxism, or both.

The correlation between TMJ and sleep apnea represents another exciting link. “In my TMJ-based practice, we typically refer three or four people every day for evaluation by a sleep doctor,” explains Spencer. “Of those in the last year, we have had just one patient who did not have sleep ap nea.” “The interesting thing is that when these patients have their sleep apnea effectively treated, either with CPAP or an oral appliance, their TMJ problems tend to improve dramatically.”

“Dentists are the best people to be looking for these problems,” continues Spencer. “We are right in the mouth. The airway is centimeters away from where the dentist is already looking. My little catchphrase when I speak to dentists is that I know you are looking at these pearly white things, so all I ask is that you direct your gaze a couple centimeters posteriorly. If you can’t see down that person’s throat, then ask if he or she is snoring. Ask is he has been known to stop breathing during sleep. Look for wear patterns on the anterior teeth. A lot of people grind their teeth forward to possibly protect their airway.”

Double Standard for Oral Appliances?

Spencer points out that medical doctors put a lot of people on CPAP, knowing full well that 20% to 40% are going to fail. Despite the sizable failure rate, CPAP remains a first choice due to its status as the “gold standard.”

Oral appliances, on the other hand, seem to merit far less latitude. “Sleep physicians can have a stack of literature that says oral appliances are effective, but if they send a patient out and that patient has a bad experience, that doctor may not send people for oral appliances anymore,” explains Spencer. “If they did that with CPAP, none of them would recommend it ever again. Sometimes it seems that CPAP is allowed to fail, but oral appliance therapy is not. However, I understand that physicians may feel this way since much of the time oral appliances have been an out of pocket expense. Dentists who are experienced in dental sleep medicine now know how to help patients receive insurance benefits, and many of these dentists have become Medicare and even Medicaid providers” (Spencer is).

In his work with Cadwell Therapeutics (www.ctisleep.com), Spencer hopes to build stronger links between sleep laboratories, dentists, and DME companies. “We are helping to train dentists and educate sleep professionals on the usefulness of oral appliance therapy,” says Spencer. “We show how a liaison between the dentist and the sleep lab can be beneficial for improved patient care, while also improving the economic health of the sleep laboratory.”

———————————————————————

Jamison Spencer, DMD, MS, is a dentist with practices limited to dental sleep medicine and craniofacial pain. He serves as chief technical officer for Cadwell Therapeutics, Inc., a company that manufacturers the Silent Sleep appliance and helps connect sleep physicians and sleep labs with trained dentists (www.ctisleep.com).

When heated humidification alone did not do the job, survey respondents verified what Plastiflex engineers suspected: heated tubes provide added comfort.

Many clinicians and sleep lab directors agree that heated tubes enhance the benefit of heated humidification. Do patients feel the same way?

Rik Langerock, vice president of Sales and Marketing for Plastiflex Healthcare, sought to answer this question with detailed post-market surveillance data. He and officials at Plastiflex decided to test the Belgium-based company’s Hybernite Rainout Control (ROC) System, which includes the proprietary Heated Breathing Tube (HBT) and Power Supply Unit (PSU), on 34 CPAP users.

Survey organizers drafted a questionnaire filled with responses that ranged from 1 to 4 (see graphs) to correspond with various criteria. The all-adult group had been using heated humidification, but not all had necessarily experienced rainout. “Our belief is that every patient who has a heated humidifier ought to have the benefit of a heated tube,” emphasizes Langerock.

Prior to using Hybernite, 31 of 34 respondents (see Fig. 1.) reported moderate to very high condensation. After Hybernite heated tubes were installed, Langerock largely got the results he expected, with a whopping 29 reporting all condensation gone, and five ratcheting it down to moderate. No one reported high or very high amounts after Hybernite installation.

“Those moderate patients were probably having huge amounts of condensation before,” adds Langerock. “Did we solve the problem? Absolutely. Did we solve it for all patients at all conditions? Not necessarily, because conditions such as humidifier settings and ambient conditions can vary.”

Condensation in the mask is also significantly reduced by using the Hybernite Heated Hose (See Fig. 2.). Since the temperature of the air arriving at the mask is warmer, there is less chance for condensation. Condensation in the mask is also caused by the air exhaled by the patient. This air is fully saturated –100% humidified – so condensation is more likely to happen.

Cold Comfort

CPAP machines blow at fairly high air speeds, and Langerock wanted to gauge the perception of cold air with a standard tube vs the Hybernite heated hose. The graph reveals a shift in the perception of cold air from very high to high with standard tubes down to none or moderate with heated (see Fig. 3.).

Under the overall banner of comfort (see Fig. 4.), Langerock went to a 5-point scale for ratings that ranged between very bad to very good. Rating “overall comfort” and “user friendliness,” Hybernite scored a vast majority of respondents rating both aspects neutral to very high.

Just one person accounted for a less than user friendly rating, but far from discounting the statistical outlier, officials searched for reasons. With a background in chemical engineering, Langerock used his meticulous nature to ask and receive reasons for all answers, whether positive or negative.

In some cases, seemingly small components added up to some frustration for a small minority of users. “The on/off switch was one of the things that surfaced,” says Langerock. “We didn’t want to make it too bulky, but some wanted a larger and easier mechanism to turn the device on and off. We respect these responses, and we are using the feedback to improve the next generation models. If it’s not a user-friendly feature, we will take it to heart and make a design change. That is extremely important.”

Noise in the Tube

Countless manufacturers have worked hard to make CPAP units slick and suitable for night stands, but the problem of noise is usually bound to strict physical limitations found in tubes. Specifically, condensation collects in the siphon and reduces the bore of the tube, leading to pressure fluctuations. “When you normally have 19 mm of internal diameter, it gets further reduced due to water droplets collecting in the tube,” explains Langerock. “The CPAP machine will try to generate the proper pressure to push the water out, and you get the gurgling sound going back and forth in that tube. Because it’s a tube, it’s like shouting in a tunnel, and it carries the noise all the way to the mask, and patients wake up because of that.”

Hybernite largely solves the problem for those with high noise levels in the mask because moisture droplets generating condensation are reduced. Hard numbers (see Fig. 5.) show that 30 out of 32 gauged noise at zero to moderate with Hybernite in place.

Dry Mouth, Dry Nose

Dry nose and mouth, together with nasal congestion (see Fig. 6 and Fig. 7.), are symptoms of suboptimal humidification, and Langerock is convinced those problems are at least partly influenced by inferior tubes. From the beginning, he says, heated humidification was designed to eliminate nose bleeds, head aches, and dry nose/mouth. “We are not necessarily solving those problems with Hybernite alone,” says Langerock. “However, when patients are using their humidifier in combination with Hybernite, the humidity created at the humidifier end is conveyed to the mask where it matters.”

Hybernite keeps water in the vapor phase, and any humidity that remains in this phase is, by definition, not condensing. “You see from these graphs that Hybernite is a valuable tool to improve humidification, because what you generate at the humidifier, Hybernite brings to the patient more effectively,” says Langerock. “The same rationale is true for dry mouth, dry nose, and nasal congestion [see Fig. 8.]. Ideally, patients should have the chance to increase the setting on their humidifier to create the optimal humidification. Without heated tubes, you would increase the chance for condensation. With Hybernite, you can absolutely increase humidity without the extra condensation. Again, everyone who has a heated humidifier should have a heated tube, just like in critical care ventilation.”

Unappreciated No More

A handsome bathroom fixture may work perfectly, but adequate pipes and a trusty hot water heater must perform flawlessly behind the scenes. For flashy new CPAP units, proper tubing often serves the same unappreciated function.

In the world of critical care ventilation, however, heated tubing is far from unappreciated. Instead, the technology is standard operating procedure because it dramatically reduces pesky condensation. Langerock, for one, believes the same standards of comfort should apply to CPAP patients.

One way to bring this convenience to sufferers of sleep disordered breathing is to make the tubes as user friendly as possible. In addition to the 22 mm standard tube connection that fits virtually all machines, the Hybernite does not draw power from the CPAP or the humidifier. “We have a separate power supply that only powers the tube,” explains Langerock. “We do not interact with any of the features of the CPAP machine or the humidifier. Whatever the manufacturer of the CPAP and humidifier desires for output, Hybernite does not change that.”

Why don’t competitors do the same thing? “Not a lot of companies have hoses as their number one focus,” muses Langerock. “Tubing is our passion, and we want to be the tubing system manufacturer of choice providing benefits to the user in terms of comfort, convenience, compliance, and cost.”

Two Years Later: Tube Makers Building Their Market Two years ago, Plastiflex decided to expand its respected tube and hose manufacturing to other industries. After an exhaustive fact-finding period that took company officials to numerous health-related trade shows, designers narrowed their focus to CPAP tubing, a niche where complaints about condensation and comfort abounded. According to Rik Langerock, vice president of Sales and Marketing for Belgium-based Plastiflex Healthcare, condensation in the breathing circuits was a persistent problem, and a key area where his company could make a difference. “We spoke to all kinds of people in the supply and value chain and it was condensation in the respiratory tubes that we found to be significant,” says Langerock. “A second related need was more comfortable air to the patient.” Comfort usually means warmer and/or more humid air, and this is where Plastiflex was able to use its considerable expertise. Other factors such as mask materials and proper fit play a role, but Langerock and his team were determined to only tackle what they knew best. “You must understand what matches with your core competency as a company,” says Langerock. “Our core competence is in the design and manufacturing of hose systems solutions.” Plastiflex engineers ultimately came up with the Hybernite Rainout Control (ROC) System, which includes the proprietary Heated Breathing Tube (HBT) and Power Supply Unit (PSU). The Hybernite HBT connects to the PSU via a plug-and-play connector, with copper wires embedded in the tubing wall. These wires generate heat that maintains air temperature inside the tube, ultimately warding off problematic condensation. 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. Targeting America and Europe was no small endeavor, but Langerock says the relative simplicity of the message has resonated on both continents. The Hybernite ROC is essentially two main parts; one is a heated breathing tube and the other is a power supply. With standard conical connectors, the Hybernite ROC has taken the role of a universal solution that can be fully used onto any flow generator or humidifier—including all types of masks that use standard tubes. “We worked on this for a long time obtaining all the proper approvals,” says Langerock. “Plastiflex Healthcare is ISO 13485 certified and QSR compliant, as are our manufacturing locations. That’s why we are able to sell the Hybernite directly to DME and sleep labs under our own name and brand.”

http://www.hybernite.com

Sleep Diagnosis and Therapy Vol 6 No 7 Dec-Jan 2011-12

The National Institutes of Health 2011 NIH Sleep Disorders Research Plan identifies research opportunities to be pursued over the next three to five years in order to spur new approaches to the prevention and treatment of sleep disorders. Recommended research initiatives include looking at the connection between sleep and circadian systems (the body’s natural 24-hour cycle), studying the influence of genetic and environmental factors that could influence a person’s sleep health, and conducting more comparative effectiveness trials to improve treatments for sleep and circadian disorders.

Availability: PDF (197KB)
Format: NHLBI produced publications : Black/White 
Page Count: 34 pages 
Subject: Sleep-Other/General Sleep 
Audience: Health Professionals 
Language: English 
Size: 8.5 in. X 11 in.
Date of Publication: 2011

Officials at Somnetics International say the diminutive Transcend CPAP unit is not only for the travel market.

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 2 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.

In addition to the unit’s compact size, judges 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, beyond the obvious benefits for travel.

“The Transcend is reimbursed under the same codes as any other CPAP on the market,” he says. “Physicians should know this is not an auto-pap, but instead a fixed pressure CPAP. We stop recommending at 16 cm of water for pressure, although the device will regulate to 20 cm. We think that anything above 16 cm really requires expiratory relief or Bi-PAP. 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.”

For DMEs and self-dispensing sleep labs looking for cash sales, Transcend can attract customers looking for secondary travel devices. “Physicians can send patients to DMEs and those DMEs can provide this as a primary device,” adds 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.”

According to Johnson, 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.”

Waterless Humidification
One crucial feature of the modern CPAP is humidification, and Transcend uses heat moisture exchange technology that hospital-based respiratory therapists have long relied on for critical care ventilation patients. “We are the only ones to do it in this context, and 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 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.

The Transcend Starter Kit (basic Transcend system) comes 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.”

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 battery system provides sufficient power to operate the device for 7 to 9 hours at a pressure setting of 14 cm H₂O. The P₈ 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.

• Can be used as a traditional CPAP using the Transcend Bedside Docking Station™ or worn on the head for maximum flexibility and mobility.

• Because it features waterless humidification, Transcend can be placed securely 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.

Sleep apnea weaved its way into the national consciousness back in 2004 when legendary NFL lineman Reggie White died in his sleep at the age of 43. The NFL-apnea connection appeared yet again in a late October 2011 article in Sports Illustrated that documented the rise and dramatic fall of the Oakland Raiders’ #1 overall pick in the 2007 draft.

Many NFL fans remember JaMarcus Russell, a 6-foot, 7-inch quarterback with a rocket arm who flamed out of the league, a victim of a questionable work ethic that may have been made worse by sleep apnea.

Russell reports that the condition contributed to lethargic practices and less-than-alert film sessions. “In the NFL, my first year, I had to be there at 6:30 before practice and be on the treadmill for an hour,” said Russell in the article by L. Jon Wertheim. “Then meetings come, I sit down, eat my fruit. We watch film, and maybe I got tired. Coach Flip [quarterback coach John DeFilippo] pulled me aside and said, ‘What are you doing for night life?’ I said, ‘Coach, I’m just chilling.’ He said, ‘I need to get you checked out.’ I did the sleep test, and they said I had apnea.”

At another point in the article, Russell’s former “life coach,” ex NBA player John Lucas, said: “JaMarcus is a good kid, I’m telling you, who just needs to find his motivation. But we still talk. Have him tell you about his sleep apnea. A lot [of his issues] come from that. And no one knows it.” The article does not mention CPAP, oral appliances, compliance, or whether Russell underwent any therapy for the condition.

Almost 7 years after her husband’s death, Reggie White’s widow went on television this week to spread the word about sleep apnea. Last week, former San Diego Chargers’ offensive lineman Aaron Taylor, along with Rolf Benirschke, a kicker for the Chargers, attended yet another media event to talk about their own battles with sleep apnea.

link to the Benirschke article.

http://www.signonsandiego.com/news/2011/nov/02/unmasking-the-problem-football-players-at-risk/

link to the Sports Illustrated article

http://sportsillustrated.cnn.com/vault/article/magazine/MAG1191566/1/index.htm