As we all know, CPAP therapy presents a challenge for your patients in regards to cleaning the CPAP equipment properly and effectively.  Minimizing the exposure to pathogens that result from inadequate cleaning is nothing short of impossible to do.  The frustration of having to take the equipment apart in order to keep the mask and CPAP machine clean is a problem for many patients.  That frustration leads to patients not taking the time to clean their equipment or potentially stop treatment lowering their compliance.  Until now. With the SoClean™ sanitizing device, that lengthy and frustrating process has been eliminated providing a solution to your patient’s frustration while keeping them healthy and compliant.

Your web site mentions personal experience with OSA. Explain how that factored into the launch of your company.

Better Rest Solutions can truly be said to have sprung from personal experience. We didn’t search the market for a niche that we thought to exploit. There are a number who work here who either suffers from, or who have a family member who suffers from obstructive sleep apnea (OSA). I include myself in this number, as my wife has OSA. Left unchecked, sleep apnea has been linked to daytime fatigue, headaches, high blood pressure, heart disease, diabetes, and even death, so you see how concerned I was when my wife received this diagnosis.

The common therapy for dealing with OSA is using a CPAP machine. My wife responded well to the therapy, but it wasn’t without its challenges, proper cleaning being one of them. She was always pretty good about making sure she cleaned her CPAP according to the manufacturer’s directions.  Despite this, she still suffered from miscellaneous respiratory problems that seemed to be connected to this therapy. As far as cleaning, she was doing everything she was supposed to do, but it still didn’t seem to be enough. This left her frustrated.

It’s about this time that the SoClean device came into development.

Talk about what led to the development of the SoClean system.

As I mentioned, I wasn’t alone in having OSA affect my life. Another OSA sufferer who I work with is Tim Leyva. He too was experiencing the ups and downs of adjusting to CPAP therapy. One of those downs was how quickly CPAP equipment built up contaminants and how arduous it was to thoroughly sanitize it. We both thought that there had to be a better way to carry out this task, so we scoured the market in search of such an approach. It turns out, there was nothing out there that would sanitize CPAP equipment to the level that we were looking for, so we decided to make one ourselves.

This was something of a departure for us, but we were strongly motivated to come up with an answer. After much research and trial-and-error, we began to assemble prototypes that showed promise. We finally arrived with the SoClean, as it appears today. This means of sanitizing CPAP equipment is like no other and it performed exactly as we hoped it would.

Describe the health benefits of using the SoClean system and how it compares to traditional methods.

What makes the SoClean really stand out above other means of CPAP cleaning is its use of activated oxygen. Activated oxygen or ozone, is one of the most powerful sanitizing agents known to man. It has the ability to destroy any biological pathogen it comes in contact with. What this means is that any virus, mold, fungus, or bacteria that might be present in the warm, moist environment of the CPAP machine will be more than 99% eradicated by the use of the SoClean. Even stubborn and dangerous pathogens like MRSA and the flu virus have proved to be no match for activated oxygen. While the activated oxygen used in this process is indeed powerful, it’s utilized in a safe way that poses no risk to the user or the environment. The SoClean converts any activated oxygen it expels during use back into the air we breathe, by means of a special filter.

Another aspect of the SoClean that deserves recognition is the ease of use. You can sanitize the entire CPAP, including the mask, hose, and reservoir without the need to disassemble. After an easy, one-time connection, the SoClean remains an integral part of the CPAP equipment. What this means is that daily sanitizing can now be carried out without the need to take apart any of the components. The former routine of disassemble/bring to the sink/hand-clean/reassemble, is now a thing of the past. It was this regular, arduous ritual that tended to turn many off from keeping their machines properly cleaned, and as a result, ripe to build up contaminants.

At Better Rest Solutions, we believe that the SoClean is an innovation that offers many important benefits. Besides the health benefits connected with using germ-free equipment, there’s the peace of mind that comes from knowing that your CPAP equipment is as safe as can be. To be connected with such a product that can positively impact the health and well being of others is truly a pleasure. My wife is happy and I’m happy.

So Clean CPAP Device

Customer Testimonial:

“In an effort to find a device to keep my husband’s equipment sanitized, my research led me to Better Rest Solutions’ SoClean device.  We were getting pretty tired of taking his whole machine apart every day and cleaning it.  It never looked or smelled clean that’s for sure!” said Lyndsay Johnson.  “We were absolutely thrilled with how much cleaner the mask and device was after using SoClean.  It literally smells ‘so clean’.”

After more than four decades studying and treating sleep disorders, Thomas Roth, PhD, has seen virtually every slumber-related malady—from mild to severe. Consumers are more aware than ever about the dangers of obstructive sleep apnea (OSA), and the medical community has spent considerable money and brainpower to better understand OSA.

Narcolepsy, on the other hand, has occasionally taken a back seat, and Roth, director of the Sleep Disorders and Research Center at Henry Ford Hospital in Detroit, believes that must change. “I want patients with narcolepsy to be diagnosed early,” says Roth, a former chairman of the World Health Organization’s Worldwide Project on Sleep and Health. “The earlier you diagnose, the less long acting the consequences are.”

Researchers know that narcolepsy is an abnormality of certain systems in the brain, and Roth says there is also a belief that it is an autoimmune disease. Determining the exact pathophysiology is the next challenge that “could ultimately lead to newer and better therapies.”

Common Misconceptions

Roth is quick to point out that there is not just one type of narcolepsy. Instead, there is essentially narcolepsy with cataplexy (a condition described as a transient loss of muscle tone that affects roughly 70% of narcoleptics) and narcolepsy without cataplexy. “I suspect in the next 5 to 10 years we are going to develop a spectrum of different narcolepsy phenotypes, and the genetic associations with those,” says Roth, who also serves as a professor in the Department of Psychiatry at Detroit-based Wayne State University School of Medicine.

When that happens, it could lead to faster and more accurate diagnoses because clinicians will be more aware of the different phenotypes. “That will lead to better treatments,” says Roth, “some of which may involve orexin, a transmitter in the brain which is deficient in patients with cataplexy.”

From the Beginning

After the identification of rapid eye movement (REM) sleep in the mid 1950s, the world of slumber opened up to serious discussion. Roth entered the field in 1970, but he estimates that “sleep disorders medicine” as a field was not formally organized until 1975.

Narcolepsy diagnosis has progressed since those early days, but there is much work to be done. In an effort to identify narcolepsy in a more efficient and accurate manner, Roth has collaborated with Jazz Pharmaceuticals in a program called Narcolepsy Link.

The idea behind Narcolepsy Link is to increase awareness in the medical community, and among patients, about how to recognize, identify, and accurately diagnose narcolepsy. “Dr. Schwartz [Jonathan R. L. Schwartz, MD] and I did a webcast several weeks ago, and we are going to do another one,” says Roth. “The whole idea is to make sure it does not take 10 years for some people to get diagnosed. Narcolepsy Link is a multi-faceted program aimed at primary care physicians, neurologists, and sleep specialists.”

Among patients, a misconception exists that narcoleptics are so sleepy that they fall asleep while talking. “While that degree of sleepiness is possible,” says Schwartz, “most narcoleptics don’t fall asleep while actively engaged in talking with someone, but some do have sleep attacks in more sedentary or monotonous situations.”

Rounding Out a Complete Program

Roth concedes that narcolepsy is not necessarily a “money maker” for the modern sleep center—at least not yet. Instead, sound narcolepsy diagnosis and care are necessary to round out a complete sleep program that addresses all facets of sleep disorders.

Much like sleep apnea, the potential patient population is massive. “About 50% of narcoleptic patients remain undiagnosed,” confirms Roth. “One of the reasons is that it takes a long time before patients get to the right doctor. It’s estimated to be 10 years on average, and it used to be much longer than that.”

Why so long? Too often, patients and clinicians alike dismissed narcolepsy as “too rare” and “something they did not have to know about.” Part of that mindset comes down to the nature of the symptoms. “The number one symptom is excessive daytime sleepiness,” says Roth. “Patients don’t talk about that. They talk about being tired and fatigued.”

The result, says Roth, is that most people get misdiagnosed with things such as depression. “They go to a doctor and talk about being tired, and physicians should be asking about snoring and/or cataplexy, but by and large they ask about depression,” he says. “Sleep disorders generally are not top of mind for most clinicians and narcolepsy is even less top of mind.”

“Many non-sleep specialists, including primary care physicians (PCPs), think of narcolepsy as a rare condition and hence may not consider it in a differential diagnosis of sleepiness,” adds Schwartz, a sleep specialist and medical director of Integris Sleep Disorders Center of Oklahoma. “Patients tell their PCPs ‘I’m tired’… instead of I’m sleepy instead of saying ‘I’m sleepy’ or ‘I can’t stay awake during the day.’ Many times these phrases lead PCPs to consider depression and other conditions as the cause of these symptoms. While sleep specialists are familiar with narcolepsy, not all physicians that practice sleep medicine evaluate for or treat narcolepsy.”

Narcolepsy Link is designed to get doctors to think out of the “depression box” and carefully explore the realm of sleep disorders. PCPs are especially prone to over-focus on depression, but sleep specialists can make the same mistake. “Sleep specialists focus on sleep apnea,” he says. “Apnea is prevalent, but narcolepsy can be a major cause of daytime sleepiness, and it has to be part of the differential diagnosis. You must ask questions about cataplexy, and you must understand what you’re looking for, which are what our educational initiatives are about. For example, how do you take a history of cataplexy? You need to know that.”

With increased awareness, Schwartz believes that PCPs will be more likely to ask more pointed questions “to rule out possible causes of sleepiness, which may include other sleep/wake disorders, medications and insufficient sleep.” The diagnostic evaluation for narcolepsy includes an overnight sleep study, followed by a daytime test called a Multiple Sleep Latency Test (MSLT).

As for a link between narcolepsy and sleep apnea, Roth says sleep apnea patients are more likely to be narcoleptics. However, he cautions that it’s a complex issue. “There is something called sleep apnea syndrome, which tends to afflict overweight males who are hypertensive,” says Roth. “Patients with narcolepsy don’t have that type of apnea. They have apnea indexes of 15 to 20, and they are not necessarily overweight.”

Through the webinars offered by Narcolepsy Link, Roth and Schwarz are covering questions that don’t often receive a lot of exposure, such as: If you have somebody with narcolepsy and apnea, which do you treat first? How do you compare the severity of narcolepsy to the severity of apnea, and how do you proceed? “Ultimately, we must expand our education to include this type of information,” concludes Roth.
 

About Thomas Roth, PhD
Thomas Roth, PhD, is the director of the Sleep Disorders and Research Center at Henry Ford Hospital in Detroit, a professor in the Department of Psychiatry at Detroit-based Wayne State University School of Medicine, and a clinical professor in the Department of Psychiatry at the University of Michigan College of Medicine in Ann Arbor.

After serving as president of the Sleep Research Society and the founding president of the National Sleep Foundation (NSF), Roth became chairman of the National Center on Sleep Disorders Research advisory board. In addition, he was a member of the board of directors of the Associated Professional Sleep Societies LLC (APSS), chaired the APSS Program Committee, and the governing board of the World Sleep Federation. Roth was instrumental in forming the Association of Sleep Disorders Centers (ASDC), now the AASM, and served as the organization’s second president. He is also the former chairman of the World Health Organization’s worldwide project on sleep and health.

About Jonathan R. L. Schwartz, MD

Jonathan R. L. Schwartz, MD is a clinical professor of Medicine at the University of Oklahoma Health Sciences Center. He also is the medical director of the Integris Sleep Disorders Center of Oklahoma, Oklahoma City. Schwartz earned his degree in medicine from Oklahoma University Medical School and Health Sciences Center, where he also completed an internship and residency in internal medicine, as well as a fellowship in pulmonary disease and critical care medicine. He is board certified in sleep disorders medicine, internal medicine, and pulmonary disease. Schwartz has served as an investigator in numerous research projects involving narcolepsy, obstructive sleep apnea, insomnia, shift work sleep disorder, and restless leg syndrome, and authored a number of articles regarding sleep disorders and their therapy.

CleveMed, Cleveland, Ohio 44103,

Introduction:

Obstructive Sleep Apnea (OSA) occurs when the soft tissues of the upper airway collapse on inspiration and cause a partial or total cessation of airflow.  There are many factors potentially involved in causing this airway collapse. They include enlarged tonsils, loss of tone in the oropharynx and palate, enlarged or posteriorly positioned tongue, fat in the pharyngeal tissue planes, and nasal obstruction causing turbulent flow through the upper airway.  A report by the National Commission on Sleep Disorders Research (1) shows that 12-20 million Americans suffer from OSA leading to more than 200,000 car crashes per year and 1/3 of fatal trucking accidents due to fatigue.  The financial cost impact is also staggering.  Estimated direct annual cost for OSA is $16 billion (2,3).  OSA has also been linked to cardiovascular and cerebrovascular implications making the disorder even more alarming than originally thought (4).  In a study by Dyken et al., sleep apnea was five times as frequent in patients with ischemic or hemorrhagic strokes (5).  Therefore, sleep disorders in general and OSA in specific present a serious national healthcare concern.

One of the most important and widely used indicators of OSA severity is the Apnea Hypopnea Index (AHI), which is defined as the average number of apneas and hypopneas episodes per hour based on a minimum of 2 hours of recorded sleep.  New regulations by the Center of Medicare and Medicaid Services (CMS) allowed the use of total recording time instead of total sleep time for ambulatory home studies since portable monitors do not typically record sleep state.  In that case, the resultant output is named the Respiratory Disturbance Index (RDI).  Typically, AHI (or RDI) > 30 indicates severe OSA, while mild to moderate OSA patients show AHI (or RDI) between 5 and 30.  AHI < 5 suggests normal breathing and is typically a target for successful OSA therapy.  According to AASM 2007 guidelines, apnea is defined as a 90% or more cessation of airflow for at least ten seconds, while hypopnea is defined as a drop of 50% or more in airflow for at least ten seconds combined with oxygen desaturations of 3% or more and at least 90% of the event’s duration must meet the amplitude reduction for hypopnea.

Home Sleep Testing per AASM Guidelines

A task force assigned by AASM concluded that HST can indeed facilitate and improve patient care provided that HST is done according to specific guidelines, which include appropriate physiological signals, scoring done by registered sleep technologist and interpretation read by a sleep physician.  The parameters recommended by the task force are: pulse oximetry, heart rate, airflow (cannula), and respiratory effort using Respiratory Inductive Plethysmography (RIP).  Additionally, the AASM strongly recommends the use of another airflow sensor (thermistor) for oral breathing and apnea confirmation.  These guidelines have been adopted as the basis for HST reimbursement by CMS and many other insurance carriers.  Therefore, fulfilling these recommendations is important for proper medical evaluation as well as to meet many insurance requirements.

Although business models and care pathways that can best utilize HST remain in flux, its adoption is growing and is expected to involve multiple stakeholders such as family physicians and their staff, sleep specialists, and others.  Therefore, technologies that offer ease-of-use, high data quality, combined with efficient workflow will become critical in the near future.

Methods:

The technology consists of two components: a web portal (SleepView.com), and a wearable patient monitor (SleepView™).  The webportal (Figure 1) is a cloud-based data management software that streamlines the various operations of HST including scheduling, device data upload, study archival, upload of additional data such as morning questionnaires, scoring and interpretation all via the internet.  To further streamline the workflow, the webportal sends email notifications to users alerting them of study progress status.  For example, once the study has been uploaded, a notification is sent to the assigned scorer for action, and once scoring is completed a similar notification is sent to the interpreting physician.  Therefore, by internet-enabling the workflow, access to HST data by qualified resources is improved allowing fast and efficient turnaround of results.

Figure 1. Illustration of the Webportal, which allows an internet- based HST workflow.

The other component of the system is SleepView (Figure 2), which measures pulse oximetry, chest effort (respiratory inductive plethysmography), airflow (pressure), airflow (thermistor), body position, snore, and heart rate.  The patient wears the following external sensors: a finger pulse oximeter, cannula, thermistor, and a respiratory inductance plethysmography effort belt (the belt is already connected to the SleepView).  The other signals do not require external sensors; snore is derived from

Figure 2. Home Sleep Monitor (SleepView).

the cannula signal, heart rate is measured from the pulse oximeter and body position is determined from an internal 3-axis accelerometer.

The accelerometer sensor and associated circuitry were designed to be of high sensitivity and fast sampling rate for the purpose of detecting slight chest movements that could help differentiate wake from sleep states.  A Rules Based Algorithm (RBA) was developed to derive sleep time by analyzing various parameters such as actigraphy and respiratory activity.  Therefore, the algorithm is comprised of both actigraphy and respiratory analysis.  First, the algorithm determines movement periods through feature extraction of 3-axis acceleration data taken from the SleepView device.   These periods of movement are trended over the course of the study and the baseline sleep/wake hypnogram is determined through preset thresholds of that trend.  Second, the algorithm determines sleep/wake epochs based on respiratory activity.  Epochs in the baseline hypnogram where there are respiratory events and desaturations are then re-marked as sleep.  Total Sleep Time (TST-PM) was estimated by subtracting the “Wake States” from Total Recording Time (TRT).

To facilitate sensor placement, light indicators are used to check for proper sensor attachment.  Improper sensor connection will light up the respective indicator alerting the patient to adjust the sensor.

Clinical Protocol - 13 patients admitted for PSG at the Cleveland Clinic sleep center were recruited for the study.  The morning following the PSG study, the patient was instructed by Cleveland Clinic staff on device use and sent home with the SleepView monitor.  A system use instruction sheet was also provided.  After the home study, the device was returned in a self-addressed package with a completed questionnaire regarding system’s ease of use.  Data was uploaded to the webportal, and run through the automated algorithm (respiratory event detection and total sleep time estimation).  The data was then manually over-read by a registered sleep technologist and report generated.  The in-lab PSG studies followed the guidelines implemented at the

Figure 3. Bland-Altman analysis showing that AHI (TST) closely approximated in lab results (bias is –3.9 ± 13.5).

Cleveland Clinic with data manually scored by a registered sleep technologist without any automated scoring and over read by a sleep physician.  The HST and in-lab studies were read by two separate technologists.

Results:

The patient demographics are shown in Table 1.

Table 1. Demographics and summary statistics for 13 patients

Patients were able to self-administer the study in the home with great success with the vast majority of patients rating usability between good and excellent (Table 2).

When compared to in-lab AHI, the web-based solution showed sensitivity of 100% and specificity of 67% (Table 3, AHI=5 was used as cutoff).  These results were identical whether the at-home AHI calculation used TRT or TST in the denominator, which suggests no impact of study duration on disease detection.

Table 3.  Sensitivity and Specificity analysis.  In lab AHI vs. At home AHI (TST)

Nevertheless, Bland-Altman analysis showed that the at home AHI calculations that used TST (AHI (TST)) were significantly closer to in-lab AHI’s than at home AHI calculations that used TRT (AHI (TRT)).  AHI (TST) exhibited a negative bias from in-lab AHI of 3.9 (Figure 3), while AHI (TRT) had a significantly worse bias of 5.6 (p < 0.01).  Therefore, although both at home results under-reported the disease, the accuracy of home AHI calculations when compared to in lab studies significantly improved when TST was used.

Discussion:

A web-based data management and scoring service that utilized a HST monitor with manual over-read capability was developed and tested in the home successfully with high sensitivity and specificity to in-lab results.  The finding that in-home testing was highly accurate in ruling-in the disease when compared to in-lab PSG is expected for monitors that utilize channel set and manual scoring methodology that are similar to that recommended by AASM.  What is more revealing in the results is the confirmation that other human factors that could influence home recordings such as sensor hookup have not compromised the fidelity of the recordings suggesting monitor’s simple operation and ease of use in the home.  This finding was further supported by patient questionnaires.

The study found that AHI (TST) and AHI (TRT) generated identical sensitivity and specificity when compared to in lab results (i.e. disease detection with both methods was identical).  However, AHI (TST) calculations yielded closer results to in lab AHI suggesting a better approximation of disease severity.  The marked improvement in AHI (TST) is partly attributed to the underlying sleep state detection algorithm used in the home monitor.  Unlike other methodologies that rely solely on actigraphy to derive sleep time, the algorithm relies on more comprehensive sleep-wake information, which merges chest actigraphy with respiratory event detection data.  The small sample size makes it difficult to derive conclusions regarding the ultimate clinical benefit of TST in home sleep evaluation.  However, this research suggests a potential role in long-term disease management which benefits from tools with more accurate tracking of disease severity.

This research supports the use of a new simplified and effective web-based methodology for sleep apnea evaluation in the home.  We believe that the successful adoption of HST will require three core competencies: 1) reliable and easy to use home technology that avoids duplicative and costly in-lab confirmation, 2) improved care coordination through streamlined workflow among various stakeholders such as sleep physicians, primary care providers and other non-sleep specialists, and administrators, and 3) a continued central role of sleep specialists in supervising and managing the disease.  Methodologies that meet these criteria will best serve patients, providers, and payers alike.

LITERATURE CITED          

1. Wake up America: A National Sleep Alert.  Report of the National Commission on Sleep Disorders Research, 1993
2. Frost and Sullivan Marketing Report, 2001, A071-56
3. Feedback Research Services, Sleep Screening and Testing Markets, Marketing report, August 2001
4. Kryger, “Principles and Practice of Sleep Medicine”, Third Edition, Saunders, 2000
5. Dyken et. al., “Investigating the relationship between stroke and sleep apnea”, Stroke 1996;27: 401-407

1. Wake up America: A National Sleep Alert. Report of the National Commission on Sleep Disorders Research, 1993
2. Frost and Sullivan Marketing Report, 2001, A071-56
3. Feedback Research Services, Sleep Screening and Testing Markets, Marketing report, August 2001
4. Kryger, “Principles and Practice of Sleep Medicine”, Third Edition, Saunders, 2000
5. Dyken et. al., “Investigating the relationship between stroke and sleep apnea”, Stroke 1996;27: 401-407

When the folks at Henry Schein Dental set their sights on dental sleep medicine training, they focused on filling the educational gaps within this market segment. 

Marketers love the one-stop-shop concept, but do customers like it? Ultimately, it all depends on the experts on staff. All too often, the “under-one-roof” locations are long on products and short on answers.

In the competitive world of dental sleep medicine training, it’s difficult to cover all the bases of economics, hardware, software, clinical considerations, and equipment. Al Simon, Director of Marketing, New and Exclusive Products, Henry Schein Dental, thinks his Melville, NY-based company has solved that problem with a new program called Sleep Complete.

“There was no one place where dentists could go to get all the education and products they needed to implement a successful dental sleep medicine program,” says Simon, who lives in Delaware. “They would have to go here to get education and there to get the product. Then they would have to figure out how to incorporate it into their dental practice.”

Integrating these elements into a busy restorative dentistry practice is the goal of Sleep Complete. One of the keys to making the vision a reality is Henry Schein’s partnership with veteran dentist and educator John H. Tucker, DMD, DICOI, DABDSM, the Erie, Pa-based owner of Erie Dental Sleep Therapy LLC. As the organization’s primary speaker, Tucker knows the challenges of rank-and-file dentists.

The Time is Right

Almost a decade ago, Henry Schein officials seriously examined the prospect of getting into dental sleep medicine training, but Simon says the timing was not right. An immature market made the venture impractical, but the idea didn’t stray far from the surface.

By 2012, insurance coverage had improved, and the market noticeably ripened. Simon pursued the training idea with gusto, taking a number of sleep courses himself and talking with key opinion leaders at the American Academy of Sleep Medicine (AASM) and the American Academy of Dental Sleep Medicine (AADSM). He found a “fragmented” patchwork of educational opportunities, and immediately thought the considerable resources of Henry Schein could change the landscape.

Other luminaries inevitably felt the same way, and Sleep Complete eventually joined the educational stage with other respected entities. Despite the considerable competition, Simon believes that Henry Schein’s umbrella approach to incorporating all products and financing to the doctor will make it easier for dentists to access and develop a successful sleep practice program. “Even more important is that we are a company that so many dentists trust,” enthuses Simon. “We focused on our education right from the start, because the education needed to be on a level that I had not seen out there during all my visits.”

After 18 months in the educational planning stage, Sleep Complete emerged as a 2-day program. Schein encourages dentists to bring team members to the training venues. During the program, these team members are separated into different workshop areas to learn about the medical billing aspects and the proprietary Dental Writer software. Meanwhile, the dentists continue to learn about the clinical aspects of sleep.

Ultimately, the whole team gets the appropriate education, and all have access to multiple industry experts for each facet of dental sleep medicine. “Representatives from Itamar Medical [makers of the WatchPAT] usually bring about 20 of their home sleep tests,” explains Simon. “Because it’s a 2-day course, we can send 20 people back to their hotel room or home that night to take a home sleep test and bring it back. We can get the results for them and show them what the report would look like. It really helps to get people to understand the process of implementation.”

Simon wants each clinician to be ready to go back to the office the next week and implement the program. He credits John H. Tucker, DMD, with making this a reality. “John was selected as one of the top 100 dentists in the country doing sleep medicine for 2012, and his practice was also selected as one of the top 100 dental practices doing sleep medicine,” says Simon. “He has been accredited by the AADSM, and John’s passion is apparent to the audience. He identifies with this audience. He’s not your typical key opinion leader. He’s been doing this for almost 10 years, and he’s been through what these guys are going to go through. They relate to him.

“If you look at many of the people on the circuit, they’ll have their own product or appliance, and John does not,” continues Simon. “He has no axe to grind. He tells everybody what they really want to know. Yes, we have the products they need, but more importantly we have the education and training to get them to the finish line.”

Partnership with The Moses

More than 100 oral appliances are currently on the market, and most do essentially the same thing—move the lower jaw forward to tighten up soft tissues in the back of the throat that block the airway. “I had several of these products made for me,” muses Simon. “I don’t have sleep apnea, but I just wanted to find out what the patient would be going through. The Moses™ appliance was the most comfortable—not that it’s the only product a dentist would use.”

According to Simon, the Dental Product Shopper and the Clinician’s Report have favorably evaluated the Moses appliance. “If there’s a reason to incorporate other products, I’m sure we will,” he says. “Maybe there are four or five appliances to satisfy every patient. We like the Moses because it activates muscles in the back of the tongue that actually move the tongue forward. And if you don’t get the tongue out of the way, you’re missing a big opportunity to correct the condition.”

Awareness High, Understanding Low

Over the last few years, Simon has spoken with a lot of people in the field of dentistry. After so many conversations, he characterizes sleep apnea awareness as high, but he thinks many dentists are so buried in traditional work that deep understanding of their opportunity to participate is lacking.

The mainstream media has actively promoted remedies for sleep disorders, and in some ways this phenomenon is forcing the hand of the dental profession. Patients will be demanding answers, and dentists increasingly need to acquire the knowledge that was only glossed over in most dental school curriculums.

“It’s true that dentists have been very cautious about getting involved with dental sleep medicine,” says Simon. “ Many feel the treatment of sleep disorders is outside the scope of their practice. It is part of our educational process to let them know that it is not.”

Physicians don’t fabricate oral appliances, because it is out of their scope of practice, and dental/medical insurance distinctions complicate matters. Dealing with these complications is the job of Sleep Completes partner, Dental Writer.

Dental Writer is a software package that makes it easier for the dental team to provide the documentation, referrals, letters, and claim forms for medical insurance that can be baffling. “Dental Writer is considered the gold standard in this area,” enthuses Simon. “It’s one of the reasons that our course breaks out the team members because they have to learn about medical insurance and how Dental Writer can help them.

“Again, education is really the key to this whole program,” adds Simon. “For example, we must constantly remind dentists that this is a medical condition with a dental solution, and they can’t diagnose it. Dentists must refer out to physicians to make this work. Anyone interested in learning more should go to http://sleepcomplete.com/ for more details.”

SIDEBAR: A Conversation with John H. Tucker, DMD, DICOI, DABDSM, owner of Erie Dental Sleep Therapy LLC, Erie, Pa.

Sleep Diagnosis & Therapy (SDT): What do fellow dentists appreciate most about your approach?

John H. Tucker, DMD: In our programs, I talk about how it can look like someone has taken a shotgun to our hygiene schedule that was completely full the day before. Most of us have seen many changes in our practices over the last five years. I was tired of going to programs and listening to people lie to me. I remember one of our attendees started to cry. She said, “This is so refreshing, because you’re telling me the truth. For years I’ve felt like such a failure in my practice because I can’t do what these speakers are telling me they do.”

SDT: How did you first get involved with sleep medicine?

Tucker: I was attending a post-graduate program at the University of Buffalo to obtain a Proficiency Certificate in Esthetic Dentistry in the late 1990s. Part of the program dealt with orthodontics. I met an ortho resident that was involved in analyzing the child’s airway prior to treatment. He explained to me why our son snored. From that point on, I was hooked on learning more about the importance of sleep for our overall health.

SDT: What did you like about Dental Writer?

Tucker: Rose’s software was the only thing available that would enable dentists to document all the information needed from a medical/legal standpoint for sleep, as well as the documentation that is critical for medical insurance.

SDT: In general, how equipped are dentists to handle the extra billing duties?

Tucker: We have entered the medical world. Most dentists have never been trained on how to bill medical, so Rose and her team at Dental Writer are pros at assisting dentists in being able to bill medical, as well as provide the needed medical documentation. Rose and I teamed up with the goal of me educating the doctors on oral appliance therapy, physiology, comorbidities associated with OSA, and she could educate the team on what is needed from a medical/legal standpoint for proper documentation and be able to bill medical insurance.”

That’s how we started. Initially, everyone wanted to expose the dental profession to the world of sleep and oral appliance therapy. But no one wanted to help us institute and bill insurance to get paid for it. That’s what Rose and I started on the quest about 3 years ago.

SDT: What attracted you to training and education?

Tucker: I found that the existing continuing education was good, but when I left the programs I felt that I had no traction. I could not implement what I’d learned because nobody was focusing on that. This is a medical disease with a dental solution.

SDT: How did you get involved with Henry Schein?

Tucker: It happened about 2 years ago. I have a personal/business relationship with some of the senior management team at Henry Schein. I have been encouraging them for the last 5 years that they should get into the dental sleep medicine market. Al Simon [Director of Marketing, New and Exclusive Products, Henry Schein Dental] is in charge of new products. They sent him to one of our programs, and Henry Schein decided to partner with Dental Writer from Nierman Practice Management, the Moses Appliance and Itamar Medical, because they have the WatchPAT, which is the home sleep testing unit.

SDT: How is the Itamar used in practice?

Tucker: We use the home sleep-testing unit like an apex locator in the clinical practice of dentistry. As dentists, we are not allowed to diagnose OSA. It must come from a physician. The use of the home sleep testing units such as the Watch PAT 200 is our apex locator. The patient takes the unit home and does a home sleep study to verify that we have efficacy of treatment with our oral appliances.

SDT: What has Henry Schein brought to the table in this process?

Tucker: Henry Schein, via Sleep Complete, has made it a complete turnkey process, because there was nothing like that out there. If you wanted an appliance, and there are over 100 FDA appliances approved for treatment of OSA, you’d have to go do your research. Then there is a multitude of home sleep testing units available. You had to figure that out. Then figure out billing medical insurance and documentation. When Schein completed Sleep Complete, they made it a one-stop shop by incorporating everything needed to adequately treat and manage the CPAP intolerant sleep patient.

SDT: What are some additional advantages that you offer?

Tucker: We help dentists to implement, institute, and most importantly bill insurance so you can get paid for it. That was my vision and why I wanted to work with Rose. Nobody was doing that. So let’s help these practices that want to get involved in dental sleep medicine get traction.

SDT: How important is the documentation aspect these days?

Tucker: Without the proper medical documentation, and being able to bill medical, practices won’t get traction. A lot of them tried to do fee for service. It’s a medical disease and here’s part of the problem. If a physician refers a patient to another health care professional, he expects the patient to be treated and managed.

SDT: Are people willing to pay cash?

Tucker: I found that people did not want to pay out of pocket. They expected their medical insurance to work. It became very apparent that we were not getting more referrals from the physicians.

SDT: What specifically did the physicians say?

Tucker: I talked to them personally, and they said, “You have failed to deliver the needed care to my patients because you want everyone to pay cash and that doesn’t work.” That was a huge step to have our peers [dentists] learn to work within the medical model. Medical insurance is far different than dental.

SDT: Do you focus solely on sleep in your practice?

Tucker: No. That’s one of the reasons I’ve been so successful in speaking to many of our peers in the profession. I’m a wet finger dentist. I still do restorative, crown and bridge, implant prosthetics and about 30% to 35% of my practice is dental sleep medicine. I’ve incorporated it, and I’m not limited to just treating OSA patients that are CPAP intolerant.

SDT: What is the level of awareness among dentists these days about sleep disordered breathing?

Tucker: From a dental standpoint, awareness is growing rapidly. However, I spoke to 300 physicians last February. Most of them had no clue that there was an alternative for the CPAP intolerant patient. My best friend is an ER doc. His son just graduated from medical school. I asked how many hours he had regarding sleep. The answer was 4 hours.