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Arizona Cardinals Join ASBA, Phoenix Police, and Pro Player Health Alliance For The Worlds Largest Sleep Apnea Awareness Event

20160126_chadiwck_19.33.50                                                                                                                                                                                                                                                                                                                    Pro Player Health Alliance is an organization dedicated to helping treat former NFL players who suffer from obstructive sleep apnea (OSA). As a result these superstar athletes then become more than just patients, but every day people who publicly support and spread the awareness of OSA at events across the nation. With a combined effort of former NFL greats, local establishments and public figures, the community as a whole can unite to direct potential patients toward dental/medical professionals who can help.


The next Pro Player Health Alliance event, aimed at improving awareness and undersDavid Gergen Larry Fitzgerald Roy Green Alan Hickey Randy Claretanding of sleep related disorders in the general public, is also a fundraiser to benefit the Phoenix Police Foundation. In addition, it will be the first official celebration to kick off the new season for the Arizona Cardinals. Shining a light on life threatening health complications that can be caused by allowing OSA to go untreated has become a primary objective for the Arizona Cardinals since partnering with Pro Player Health Alliance. Location and time of the public awareness event and fundraiser will be Tuesday September 6, 2016 at 6:30 p.m. to close at Padre Murphy’s 4338 West Bell Road, Phoenix AZ 85308. It is expected that this event will draw over 5,000 thousand attendees.

Roy Green, NFL legend and former Cardinals WR/DB has said, “If I had met David Gergen years ago, I may not have had to experience having a heart attack, let alone three heart attacks and two strokes. I am extremely grateful for what he’s done for me and my former teammates and I’m glad to be a part of spreading awareness on sleep apnea so others don’t have to go through what I did.”

Pro Player Health Alliance President David Gergen, owner of Gergen’s Sleep Appliance Lab and Executive Director of the American Sleep and Breathing Academy is an icon throughout the dental sleep community and will be the MC for the event. David will be on hand to help the public meet their favorite player and to share his extensive knowledge of sleep disorders including the dental treatment of sleep apnea.

David Gergen on stage








“Over the years more and more retired NFL greats have contacted me regarding their sleep apnea. I am happy to refer them to a dentist or medical doctor who can help them. It became very obvious that the general population was having the same issue. Roy Green and I decided to help the retired players and improve awareness of sleep disorders by promoting large public events.” – David Gergen

ASBA First Amendment Action Time FMCSA-2015-0419

“In the Matter of Medical Certification of Transportation Workers in Safety Sensitive Positions; Individuals Exhibiting Risk Factors for Moderate-to-Severe Obstructive Sleep Apnea”

FMCSA-2015-0419 – Deadline for Comment is June 8, 2016

Dear Colleagues,

Following up on the FMCSA-2015-0419 presentation during the recent Sleep & Wellness conference on behalf of the American Sleep and Breathing Academy, please note the following important instructions with regards to comment.

a) Review comments!docketDetail;D=FMCSA-2015-0419

b) Add comment!submitComment;D=FMCSA-2015-0419-0001

When commenting:

i. Present your credentials and relevant experience. Be sure to mention you are a member of the American Sleep and Breathing Academy ‘ASBA’.

ii. Be concise and support your claims

iii. Add scientific evidence from dental sleep medicine sources and literature. Include scientific studies on oral appliance therapy and your own experience as an expert.

iv. Address trade-offs and opposing views.

v. Include the costs and benefits to patients of your approach.  It is especially important for oral appliance therapy to address costs and compliance.

Comments are not votes, but one well supported comment is more influential than a thousand form letters.

The ASBA needs to speak up with one voice about this important issue.

Juggernaut of The Jaw

David Gergen rolled out of bed on September 12, 1981, and had his career “aha” moment. Gergen knew he was going to be an orthodontic technician, and he knew he was going to help people all over the country. Since then, he has built one of America’s most successful dental labs in Phoenix, Arizona, revolutionized the sleep industry through oral appliances and special programs, and was once voted top dental laboratory technician in the country.

For more than 20 years in Phoenix, Gergen spent the fall coaching POP Warner football and/or high school football. Most of the important lessons of his life were learned either watching football legends, creating challenges for himself on the field, or teaching children the values of courage and teamwork on the field.

It comes as no surprise that Gergen, father of nine children, would focus a good deal of his professional life to helping children achieve their goals. Gergen is a certified dental technician, and some would say a master technician that children and adults have relied on for excellent results.

In his professional life, Gergen worked to straighten teeth for cosmetic reasons, and to help create functional oral structures for patients with severe trauma or developmental issues. Recently, attention has turned to the effects of poor jaw position on children. “A small airway often forces children to breathe through their mouth and posture their head forward resulting in rounded shoulders and back problems,” explains Gergen. “Continuing this position over many years will create permanent changes in posture. Poor breathing habits can result in heart and lung problems in later life.”

After 30 years of establishing better jaw and tooth function through orthodontics, Gergen decided that he was going to focus on the airway. His pediatric sleep appliance is a direct result of all of this experience and experimentation. Despite the growing evidence, Gergen laments that, “Some clinicians still believe that oral appliances are ineffective. As a dental sleep industry, I don’t think we’ve done a good enough job educating the public and physicians.”


Gergen’s pediatric sleep appliance is worn on the child’s upper and lower teeth, and gives dentists an opportunity to guide the growth of patients’ teeth— more importantly, the jaw and the airway. Expansion of the upper jaw will create more room for the tongue to posture forward and open the airway.

“The simple shape and construction of the lower appliance will help stage the growth of the child’s teeth allowing the dentist to control the growth rates of the teeth for maximum cosmetic and palliative effect,” enthuses Gergen. “One of the best parts of the treatment is that all the time this growth is being controlled, the jaw is held slightly forward creating an open airway leading to better and deeper sleep patterns.”

What is the Expected Roll out for the Remainder of 2013?

Gergen has been working with Hall of Fame NFL great Mike Haynes, whose son is Pop Warner age and grinds his teeth in his sleep. This is what drove Gergen to come up with the first pediatric sleep appliance.

Mike Haynes is no stranger to health issues from his experience with prostate cancer and concussions. Both Gergen and Haynes know the value of an oral appliance worn during the day, or while playing a sport. Proper jaw position has been shown to improve agility, performance, and strength.

We got our CE mark and we are beginning our launch in Europe. We received our 510k approval in May. Our game plan now is that we are going to launch in Europe, and then toward the end of summer we’ll be launching in the U.S. By the end of this year, and going into 2014, we plan to be at full scale.

The concept of jaw position as a fundamental piece of sports performance is not new. Dr. Harold Gelb introduced this concept in his early work in the 1970s. The culmination of his work in improved performance was the 2000 Baltimore Ravens who triumphed over the New York Giants to win Super Bowl XXXV.

Every player on the team wore a custom oral appliance that positioned the jaw in Dr. Gelb’s Jaw position called the Gelb 4/7 position. Since that time, professional sportsmen all over the world have been adopting a daytime mouth guard to protect them from injury and improve their performance.

In a 2012 dental conference in Las Vegas, Dr. Gelb paid Gergen a high compliment, saying, “David Gergen is the finest technician ever to live. He is heads and tails above the competition.” Gergen was honoring Dr. Gelb for his 65th year in dentistry at the presentation, and Dr. Gelb also mentioned, “There are two legends in this room.”

“To say that David Gergen is a juggernaut of the jaw is to describe the part that is most obvious to all,” adds Rudi M. Ferrate, MD, DABSM and Sleep medicine specialist. “The part most people miss at first is the strength of his character, his passion for excellence, and his humble desire to help as many people as possible. He could easily sit back and enjoy the fruits of his business, but instead he spends his time and resources promoting education and awareness about sleep disorders. He is single handedly the most important force bringing sleep physicians and sleep dentists together and now is using his skills and reputation to bring everyone else on board—from legislators to sports legends.”

Improvement on Many Levels

Children undergoing standard orthodontic care have noticed their grades improve, sometimes dramatically. In the past, this would have been attributed to improved self-image or a growth spurt. Today, experts have measured the improved sleep patterns and the increase in airway size that comes from a better jaw position. These patients breathe better at night, and wake up more able to deal with the demands of the day.

When Gergen decided to change the world of sleep medicine, it seemed like something outside the realms of possibility. How could a certified dental lab tech from Arizona manifestly change the sleep industry? It began by assembling a winning team and deciding to help people treat their sleep disorders in partnership with their dentists.

In August 2011, Gergen’s first training program in sleep was presented to a group of 25 doctors in Sonoma, Calif. He continues to hold special seminars and educational meetings. In a market where there are companies running dental sleep medicine programs every week, each successive Gergen’s Orthodontic Lab program has gotten better in one really significant
way: the team.

Gergen’s Orthodontic Lab’s team is achieving a seasoned balance that makes these meetings better. Each educator has his specialty. Each topic is covered thoroughly without overreach that comes from trying to extrapolate data points to gloss over the unknown or unknowable. When Gergen was Arizona’s most successful POP Warner football coach, he learned that individual efforts often do not make the grade, and it is teams that win.

Gergen’s new meetings will be remembered as the first time that retired NFL players used their celebrity status to introduce the urgent need for sleep diagnosis and therapy to the general public.

He could easily sit back and enjoy the fruits of his business, but instead he spends his time and resources promoting education and awareness about sleep disorders.

“Pro Player Health Alliance was created to treat the sleep health needs of retired NFL players,” explains Gergen, “while at the same time raising awareness of sleep apnea as a silent killer.”

Dr. Archie Roberts, founder of the NFL HOPE program and retired NFL player, has been one of Gergen’s keynote speakers. Roberts established the much higher incidence of OSA and heart disease in the general population. He asked Gergen to be the sleep apnea director in the program they’re launching at the Mayo Clinic in Scottsdale, Arizona, on August 14, 2013.

Carl Eller, Larry Fitzgerald, Warren Moon, Roy Green, Dave Krieg, Isiah Robertson, Eric Dickerson, Mike Haynes, Tony Dorsett, Matt Blair, Chuck Foreman, and Derrek Kennard were all excellent football players, and some have been inducted into the Hall of Fame. They are all sleep apnea patients who are contributing to the field of sleep medicine and sharing their experiences with the general public.

The results are more diagnostic tests and, hopefully, reversing the trend of undiagnosed sleep apnea. Mike even asked Gergen recently to make an agility guard for his son to help him with his football performance. He also asked Gergen to have his son looked at for pediatric sleep.

With long-time friend, Dr. Elliott Alpher, Gergen met with the Secretary of the Department of Transportation, and his cabinet, on behalf of the Trucker’s Union, to begin using his oral appliance, made with a micro-recorder manufactured by Braebon. The micro-reader can monitor commercial
truck drivers’ compliance.

On the horizon is an upcoming Pro Player Health Alliance event in New York, a presentation with Dr. Brad Eli during sleep symposium at the Super Bowl (scheduled for February 2, 2014 in East Rutherford, NJ), and a seminar in Las Vegas with Dr. Brock Rendeau. “Rendeau is one of North America’s most sought after clinicians, and without a doubt one of the most creative speakers on the topic of functional orthodontic treatment,” says Gergen.

Gergen will remain at the center of these programs. He will be building teams, asking hard questions, and the sleep industry will be better for it.

David Gergen At a Glance

• CDT and president of Pro Player Health Alliance and Gergen’s Orthodontic Lab;

• Honored as “The Finest Orthodontic Technician in the Country” by Columbus Dental in 1986.

• Executive Director of the dental wing of the American Sleep and Breathing Academy, a national interdisciplinary academy dedicated to sleep training and education with over 60,000 members.

• Personal technician for Dr. Robert Ricketts, Dr. Ronald Roth, Dr. A. Paul Serrano, Dr. Clark Jones, Dr. Harold Gelb, Dr. Joseph R. Cohen, Dr. Rodney Willey, Dr. Allan Bernstein, and Dr. Thien Pham.

• Winner of the National Leadership award for Arizona Small Businessman of the Year in 2004.

Pilots Push Back on FAA Apnea Screening Policy

The Aircraft Owners and Pilots Association (AOPA) is asking the Federal Aviation Administration to indefinitely suspend a new policy that would require some pilots to be screened and, if necessary, treated for obstructive sleep apnea before receiving a medical certificate.

An article posted on the AOPA Web site reports that at first, the screening would apply to pilots with a body mass index (BMI) over 40. Over time, the FAA would lower the BMI requirement, compelling more pilots to be screened by a board-certified sleep specialist. The policy is the result of NTSB recommendations, but AOPA argues that there is no evidence to support the need for such screenings among general aviation pilots.

A look at the comment section following the article shows widespread support for suspending the policy. “[The FAA] admits to no data on the effects of sleep apnea on pilot performance, and they target the entire pilot database anyway,” writes one commenter. “These are not decisions based on aviation safety. They are a nanny style directive.”

“This policy seems to be based on one incident involving an airline flight,” said Rob Hackman, AOPA vice president of Regulatory Affairs. “In that case, the crew fell asleep and missed their destination but woke up and landed safely. Analysis of a decade of fatal general aviation accidents by the General Aviation Joint Steering Committee didn’t identify obstructive sleep apnea as a contributing or causal factor in any of the accidents studied.”

AOPA is composing a formal letter to FAA Federal Flight Surgeon Dr. Fred Tilton asking him not to implement the new policy and noting that there was no public comment period before the policy was announced. The new requirements could potentially affect thousands of pilots, adding to what AOPA calls the already significant backlog for processing special issuance medicals.

In 2011, the FAA identified 124,973 airmen who are considered obese, making them potential candidates for screening. According to reporter Elizabeth Tennyson, the new policy grew out of a 2009 NTSB recommendation that the FAA change the airman medical application to include questions about any previous diagnosis of obstructive sleep apnea as well as the presence of risk factors for the disorder.

The recommendation also asked the FAA to implement a program to require pilots at high risk for obstructive sleep apnea to be evaluated and, if needed, treated before being granted medical certification.

Source: AOPA

Scope of Practice: “The Most Misunderstood Concept in Dentistry”

 Ken Berley, DDS, JD

         It is unusual for a week to go by where I do not read an article or position paper from some organization or association that purports to outline the “Scope of Practice” for some discipline or field of dentistry.  As I review these position papers, it is not difficult to identify the agenda of the organization that is proffering the alleged scope of practice proclamation.  We ALL have certain agendas!  I am not saying that it is illegal or even wrong to have an agenda.   I do however, feel that it is wrong for any organization to imply that it is illegal for a dentist to provide treatment contrary to their self-serving “Scope of Practice – Position Paper”.

            A dentist’s scope of practice is divided into three separate and identifiable parts:

A.  Dental Practice Act/Board of Dental Examiners

—  “The Black Letter LAW”

—  Any rulings of the Board of Dental Examiners

  1. B.    Education and training

C.  Employer/Insurance

—  Limitations placed by the Dentist’s place of employment or insurance coverage.

We will take a look at each of these areas as they relate to your “Scope of Practice”.

1.          Dental Practice Act/Board of Dental Examiners:   

Within the definition of the “practice of dentistry” in your state’s dental practice act, is the description of your scope of practice.  This is the terminology used by your State Board of Dental Examiners to define the procedures, actions, and processes that are permitted by licensed dentists in your state.  Most states have adopted the ADA model definition or some variation thereof.  It reads as follows:

ADA’s Definition of Dentistry:  

      The evaluation, diagnosis, prevention and/or treatment (nonsurgical, surgical or related procedures) of diseases, disorders and/or conditions of the oral cavity, maxillofacial area and/or the adjacent and associated structures and their impact on the human body; provided by a dentist, within the scope of his/her education, training and experience, in accordance with the ethics of the profession and applicable law.
Adopted: ADA Resolution 1997

Obviously, this model definition is only a model for state boards to reference. However, it has received favorable review and acceptance by many state boards.  As you can see, the definition of the practice of dentistry is very broad in scope.  Each state’s dental practice act and the included definition of the practice of dentistry, is much like our U.S. Constitution in that it is an evolving document which changes and grows as the practice of dentistry progresses. The definition of the practice of dentistry (Scope of Practice) is written so that it purposefully overlaps other professions.  If one reviews the “scope of practice” for Dentists and ENTs, one will find that there is a great amount of overlap.  Additionally, all dental practice acts are searchable online making access easy for all practitioners.

I personally practice in Northwest Arkansas and the Arkansas Legislature has adopted the ADA Model with some modifications.  This is my Scope of Practice:

—   17-82-102. DEFINITIONS.

—  (1)(A) “Practicing dentistry” means:

—  (i) The evaluation, diagnosis, prevention and treatment by nonsurgical, surgical or related procedures of diseases, disorders and conditions of the oral cavity, maxillofacial area and the adjacent and associated structures and their impact on the human body, but not for the purpose of treating diseases, disorders and conditions unrelated to the oral cavity, maxillofacial area and the adjacent and associated structures……..


Notice that my scope of practice is for any type of treatment, of any type of condition, of the “oral cavity, maxillofacial area and the adjacent and associated structures and their impact on the human body…”.

So, any condition that has any oral-facial component is well within the definition of the practice of Dentistry for the State of Arkansas.  The State Board of Dental Examiners can then limit these broad privileges if the occasion arises.  For example, in my 30 plus years of practicing dentistry, the Arkansas regulations and requirements for providing sedation have changed several times.  While sedation broadly falls within the scope of practice for a dentist in Arkansas, the Arkansas Board of Dental Examiners have promulgated regulations defining the educational requirements and office/emergency equipment necessary to provide this service.

2.         Education and training

As a general statement, one’s education and training is far more important in determining a dentist’s “SCOPE OF PRACTICE” than your state’s dental practice act.  All dental practice acts are so broad they encompass all the areas of dentistry as well as many areas of medicine.  In most states, oral surgeons and general dentist both operate under the same definition of the practice of dentistry even though, the scope of their practices are vastly different.

So what is the difference?  Levels of education!!!  One’s training is the primary determinate in establishing one’s SCOPE OF PRACTICE!!!!!!  Using that premise it is easy to see that two general dentists practicing next door to each other can have different scopes.  Personally, I love implant dentistry.  In our office we routinely perform sinus lifts, ridge augmentations, PRP for grafting and wound healing, and placement of implants.  I placed my first blade implant in 1984.  So the question remains, what is my scope of practice compared to the dentist next door?  The difference is the 5000 hours of continuing education which qualifies me to practice at the level that I have chosen.

Therefore, general dentists in the same state can have different Scopes of Practice. Additionally, each dentist can choose to change his or her scope of practice by becoming competent in a new area of study.  From a medical/legal stand-point the issue is whether adequate levels of training have been achieved to insure competence.  Each practitioner should be prepared to document his training and experience to the Board of Dental Examiners or a jury if the need arises.   In each new area of study, practitioners should document courses taken and the conventions attended keeping a list of the dates of each course and the names of lecturers.  Additionally, one should become a member of the prominent professional associations in that area and routinely read the appropriate journals.


As we all know, not all dentists work for themselves.  Many of us are employed in various capacities where our employer determines the services and procedures that we perform.  In that situation, our employer may limit our scope of practice and establish guidelines for that organization.  For example, it is likely within the scope of practice for all dentists to remove impacted wisdom teeth. However, not every office is prepared to offer this service.  Limitations placed by the dentist’s place of employment or available insurance coverage, are a real restriction to one’s scope.  I would not recommend that any dentist add a new procedure to his practice without consulting his liability/malpractice carrier to insure coverage.

How do you determine whether a new procedure or service is within your scope of practice?

  1. Review your states definition of DENTISTRY.
    1. Within that definition is your “Scope of Practice”
    2. Review any rulings from your Board of Dental Examiners for restrictions relative to the therapy/procedure in question.
      1. If any adverse rulings have been handed down, was the limitation based on education levels or was there a prohibition of that procedure?
      2. If the procedure falls broadly within the definition of dentistry and no determination or ruling has been made to the contrary by your Board of Examiners, there is a legal presumption that the technique/treatment/procedure is within your scope of practice.
  1. Education:
    1. Join the major professional organizations in your new area of study.  “Look Like You Are One of the Group”
    2. Read the professional journals regularly and keep notes and abstracts which you can reference for review.
    3. Attend as many continuing education courses as possible to get up to speed as fast as you can.
      1. Document all courses taken.
        1. Name of course
        2. Presenter
        3. Date
        4. Sponsoring organization
  1. Employer/Insurance
    1. Are there any restrictions that have been placed on you by your employer that will limit your ability to provide this treatment?
    2. Will your insurance company provide adequate coverage for this procedure?  If the answer is no, can you pay an additional premium to get the coverage?

Do State Medical Practice Acts limit my “Scope of Practice”?

This is a common misconception among dentists.  It is amazing to me that dentists think they are prohibited from treating any condition that may also be treated by an MD. This could not be farther from the truth.  There is broad overlap in the definitions of the practice of medicine and the practice of dentistry. However, the practice of dentistry and the practice of medicine are governed by separate boards and are regulated separately.  It is the intention of state legislatures that the disciplines work together to provide care for our patients.  Additionally, the medical practice act of each state specifically exempts the practice of dentistry from any prohibitions expounded within the Medical Practice Acts.  For example the Arkansas Medical Practice Act defines the practice of medicine as:

—   (2) “Practice of medicine” means:

—  (A) Holding out one’s self to the public within this state as being able to diagnose, treat, prescribe for, palliate, or prevent any human disease, ailment, injury, deformity, or physical or mental condition, whether by the use of drugs, surgery, manipulation, electricity, or any physical, mechanical, or other means whatsoever;

—  (B) Suggesting, recommending, prescribing, or administering any form of treatment, operation, or healing for the intended palliation, relief, or cure of any physical or mental disease, ailment, injury, condition, or defect of any person with the intention of receiving, either directly or indirectly, any fee, gift, or compensation whatsoever;

—  (C) The maintenance of an office or other place to meet persons for the purpose of examining or treating persons afflicted with disease, injury, or defect of body or mind;

—  (D) Using the title “M.D.,” “M.B.,” “D.O.,” “Physician,” “Surgeon,” or any word or abbreviation to indicate or induce others to believe that one is engaged in the diagnosis or treatment of persons afflicted with disease, injury, or defect of body or mind, except as otherwise expressly permitted by the laws of this state relating to the practice of any limited field of the healing arts; or

—  (E) Performing any kind of surgical operation upon a human being.

—  17-95-203. Exemptions.

—  Nothing herein shall be construed to prohibit or to require a license with respect to any of the following acts:

—   (3) The practice of the following professions as defined by the laws of this state, which Sub-Chapters 2-4 of this chapter are not intended to limit, restrict, enlarge, or alter the privileges and practice of, as provided by the laws of this state:

—  (A) Dentistry;

—  (B) Podiatry;

—  (C) Optometry;

—  (D) Chiropractic;

—  (E) Cosmetology.

Therefore, as long as the new treatment or procedure falls broadly within your state’s definition of the practice of dentistry, you are exempted from any regulations, restrictions or requirements enacted by your state’s Medical Practice Act.  However, it is critically important for each dentist to know when to refer!  Know your limitations and levels of competence.  If in doubt, send it out!!!!

In Conclusion:  Every dentist is ultimately in control of his or her Scope of Practice.  Very few limitations have been placed in our way.  In my opinion this has been purposefully done to encourage each practitioner to expand his or her knowledge and abilities to the fullest.  We should not become stagnant!  With that in mind, never allow any individual or organization other than your state’s Board of Dental Examiners, to dictate your “Scope of Practice”.  In my career, I have repeatedly been told that I cannot perform certain procedures because I am just a “Dentist”.  These many encounters have provided an incentive to expand my level of knowledge!

So where do we go in the future?  The sky is the LIMIT!!!


Respectfully Submitted:

Ken Berley DDS, JD



—  Contact attorney in your state

—  Seek an opinion from an attorney with experience practicing before your state dental board



Driving With Your Eyes Open!

John Viviano DDS, discusses the findings of this previously published study in ‘Respiration 2011 2: 20’ Aarab G, Lobbezoo F, et al.

Airway Orthotics vs. nCPAP; which is better? Previous randomized controlled trials investigating this have found nasal continuous positive airway pressure (nCPAP) to be superior to Airway Orthotic therapy (AO).  However, in most of these studies, only nCPAP was titrated objectively but not the AO. In order to establish an unbiased comparison between these treatment modalities, the AO should be titrated objectively as well.

The purpose of the cited study was to compare the treatment effects of a “titrated AO” with those of “nCPAP” and an “intraoral placebo device”.  Sixty-four mild to moderate patients with OSA were randomly assigned to three groups: AO, nCPAP and placebo device. From all patients, two in-lab sleep study recordings were obtained; one before treatment and one after approximately 6 months of treatment.

The results demonstrated that the change in the apnea-hypopnea index (AHI) between the baseline and therapy evaluations differed significantly between the three groups. However, no statistical difference was found between the AO and nCPAP therapy, whereas the changes in AHI in these groups were significantly larger than those in the placebo group.

The authors concluded no clinically relevant difference between AOs and nCPAP in the treatment of mild to moderate OSA when both are titrated objectively. A number of very good, user-friendly ambulatory sleep screeners are available for Dentists to use. Consider it something like driving with your eyes open!

Discussing Oral Appliances vs. CPAP with Physicians

Every professional who treats sleep apnea wants to recommend the most effective therapy for each individual patient.  If only we had a tool to predict such a positive match!

Study after study shows that CPAP, applied effectively, will resolve all forms of sleep disordered breathing.  Unfortunately many studies also show that CPAP is not well accepted by patients, thus alternative therapies have been pursued almost since obstructive sleep apnea was described.

As dentists seek to form collaborative care relationships with diagnosing physicians, it is necessary to back up claims of effectiveness of the dental appliance therapy we provide.

Two recent articles can help support dental interventions:

Efficacy of An Adjustable Oral Appliance and Comparison to Continuous Positive Airway Pressure for the Treatment of Obstructive Sleep Apnea Syndrome
Aaron B. Holley, Christopher J. Lettieri and Anita A. Shah
Chest; June 2, 2011; DOI 10.1378/chest.10-2851

Full Article Available Here

The comparison of CPAP and OA in treatment of patients with OSA: A systematic review and 
Wenyang Li1, MD, Lin Xiao2, PHD, Jing Hu1*, PHD
RESPIRATORY CARE . Published on January, 2013  DOI: 10.4187/respcare.02245

Full Article Available Here

Each of these well written papers show that many measurements of sleep-related diagnostics such as Epworth, SQALI, and oximetry are equally treated with either CPAP or OAT.  Patient preference continues to be for OAT while AHI reduction is best accomplished by CPAP, especially as the diagnosed AHI rises above 30. This was summarized well recently:

Eur Respir J. 2012 May;39(5):1241-7. doi: 10.1183/09031936.00144711. Epub 2011 Nov 10.

Non-CPAP therapies in obstructive sleep apnoea: mandibular advancement device therapy.
Marklund M, Verbraecken J, Randerath W 

Read Abstract

How can the interested dentist use this information?  Your sleep physicians may understand that dentists have something to offer their patients, but are not as sure about effectiveness.

Dentists mostly treat disease with procedures:  we surgically remove decay and restore the void with various materials. We mechanically reduce infection and rely on the body to heal tissue lesions. We can do this for years without much concern for scientific basis of why we do what we do.

Physicians tend to pay much more attention to research and publications than dentists do. This fact means that as dentists seek to gain a legitimate role in the treatment of medical patients, we must provide properly researched data to support our therapeutic option.

Of course, there are research savvy dentists and CPAP-blinded physicians. Focusing on improving the health of our community depends -on all parties growing together.

Steve Carstensen, DDS
Bellevue, WA

DentiTrac® SomnoMed Signs Exclusive Agreement with BRAEBON Medical for Compliance Measurement

December 2012: SomnoMed Limited announced today that it has entered into a contract with
BRAEBON Medical Corporation, a Canadian company based in Ottawa, to become a worldwide distributor
for the DentiTrac® Base Station and DentiTrac® Micro-Recorder with exclusivity in Europe and parts of Asia
Pacific and in SomnoDent’s oral appliance design class in North America.
The DentiTrac® system has been developed by BRAEBON over the last few years. It is a micro recorder,
which will be imbedded in SomnoDent® oral appliances and monitors the wearing time of the SomnoDent®
device, as well as gather other information (oral temperature, movements and head position) relating to the
patient’s sleep pattern during the night. Information is transmitted wirelessly to the DentiTrac® base station
and from there to the BRAEBON cloud. The detailed information about the patient’s use of the
SomnoDent® device, in short one minute intervals during every night of use over a long period of time, can
then be downloaded by a medical specialist, SomnoMed network dentists or other authorized entities.
“We are very excited about our agreement with BRAEBON. Compliance measurement is the last question
to be answered when it comes to oral appliance therapy. After the introduction of SomnoMed MATRx™ in
June this year, which delivers immediate proof as to the efficacy of the SomnoDent® treatment and the
optimal positioning of the SomnoDent® device, the question whether we can prove patient’s compliance
remained as the last question to be answered from a medical point of view,” said Dr. Peter Neustadt,
Executive Chairman of SomnoMed.
“The ability to prove compliance will widen the door to the medical market. The DentiTrac® system cannot
be circumvented and delivers data in short intervals during the night. We believe this will not only allow us
to broaden the acceptance from medical specialists but also gain greater support from insurers around the
world, who require proof that the sleep apnea patient is compliant in their treatment. Compliance is now a
major issue with CPAP and it is understandable that insurers demand compliance measurement. Clinical
research shows that compliance is very high with the use of SomnoDent®, however DentiTrac® will now
allow SomnoMed to enter into discussions with professional organisations which insist on nightly treatment
of their sleep apnea diagnosed members (e.g. the US Trucker’s Association with over 11 million members)
and demand proof of compliance,” said Dr. Neustadt.
The long term contract with BRAEBON gives SomnoMed exclusivity to market and distribute the
DentiTrac® system in its application for oral appliance therapy in Europe and parts of Asia-Pacific and
exclusivity for oral appliances in the dorsal fin oral appliance class of SomnoDent® in North America.
DentiTrac® will become available during 2013, once all necessary regulatory approvals have been
Dr. Richard Bonato, co-founder and President and CEO of BRAEBON said, “We are very pleased to have
joined forces with SomnoMed for the worldwide distribution of DentiTrac®. BRAEBON has invested years of
development in this system and has created a system, which we believe is setting a high bar for accurate
compliance measurement in oral appliances. SomnoMed is the global leader in dental sleep medicine and
because of the quality of their SomnoDent® products and their global reach it is the ideal partner for our
DentiTrac® system. We believe the worldwide potential for DentiTrac® is significant. Compliance
measurement will contribute to the growth of oral appliance therapy as an alternative to CPAP. BRAEBON
is in the process of obtaining regulatory approval and anticipate receiving this shortly for Canada, and
Europe. We will be ready to supply product as soon as the DentiTrac® is cleared in a territory
Source: SomnoMed

Sleepy Drivers

Signals are being given that the National Transportation Safety Board (NTSB) and Federal Motor Carrier Safety Administration (FMCSA) are nearing sleep apnea testing regulations for truckers.  Everyone is concerned about safety, but none of the interested parties wants another regulation that is just going to be a nuisance costing more money and posing greater risk liability.  Many legitimate objections have been raised:

  • What is the scientific basis for diagnosis of sleep apnea that mandates treatment?
  • What is the scientific basis for standards of successful treatment?
  • What is a reasonable time period to allow from diagnosis to successful treatment?
  • Being diagnosed with sleep apnea is a “scarlet letter” decreasing employment opportunities and health insurability should a trucker terminate employment.
  • “The National Sleep Foundation appears to be a lobby for sleep companies trying to fleece truckers.”
  • There is little or no data showing that truckers are tired or that drivers with sleep apnea are causing large numbers of wrecks
  • Federal regulations already require a physician to examine for sleep apnea
  • Truckers who would normally bring up the subject of daytime sleepiness with their physicians won’t do so if the threat of a $2,000 to $5,000 laboratory sleep study hangs over them
  • Most truckers’ benefits will not cover costs in that price range
  • CPAP and pharmaceutical manufacturers pay millions of dollars in perks and unreported cash to physicians for listening to their pitch.  Medical consumers cannot make independent and informed purchasing decisions listening to advice from physicians getting such “Sunshine Payments”.

According to the white paper by ACS (Affiliated Computer Services, Inc.), a Xerox Company in business process and information technology services, “The real problem the trucking industry is currently facing is sleep apnea.”  They suggest in this paper that the following steps would be an adequate solution:

  1. Truck drivers will get screened for sleep apnea by their employers at a credible sleep lab.

2. Drivers found to have sleep apnea will be required to receive medical treatment.

3. Carriers will have to ensure their drivers with sleep apnea are taking their treatments.

4. Drivers receiving treatments will be required to remove data from their CPAP and upload the data on a device which would transfer the results to a sleep lab.

5. A receipt will be printed from the printer located next to the computer, giving the driver proof of their upload.

6. The data will then be centralized to distribute data to the driver, carrier, and physician. This data must be transparent so all parties can manage and document the findings.

7. The data will have the ability to be shared and documented through a web-portal.  The web-portal will provide substantiated analytical proof of compliance that the driver is receiving proper medical attention for their sleep apnea.

Does this sound like they want to impose a police state, “big brother is watching you” dictum or what?  It could reasonably be construed as an attempt by a big CPAP/sleep lab consortium to fleece the trucking industry with increased liability and risk, and truckers with bearing exorbitant regulatory costs.  This white paper does not give any alternative solutions to CPAP and overnight sleep lab testing.  ACS found this very serious problem and they can provide all the answers.  But do they really?

For driver safety regulations to be effective, they must be based on a win-win situation.  Let’s impose common sense to the problem.  There are certain points that seem obvious, undeniable and logical.

  • Studies of all human drivers have shown a link between sleepiness, untreated apnea and motor vehicle accidents.
  • Drivers with sleep apnea do not sleep as well as drivers who do not have sleep apnea.
  • Tired, sleepy drivers are more likely to crash than drivers who are alert and well-rested.
  • Obesity, diabetes, smoking, high blood pressure, cardiovascular disease, male gender and large neck size have all been linked to sleep apnea.
  • People having these characteristics should be referred to their physicians for sleep testing and proper treatment if indicated.

These points are the basis for the recommendations of the National Review Board to the Federal Motor Safety Administration.  All references specific to truckers were removed.  It is easy to see in this context that good principles of road safety apply to all motorists – not just truckers.  This is not arguable.  The unhappiness is over implementation of these guidelines relative to truckers.  There appear to be commercial interests that want to make these into rules specific to truckers.  We like to think of the United States of America as a free country.  Events comparable to September 11, 2001 however have required some compromises of freedom for security and safety.

In July 1997 a college student, Maggie McDonnell was struck and killed in a head-on motor vehicle accident by a driver who fell asleep at the wheel.  The driver at fault had not slept in over 30 hours.  Because there were no drowsy driving laws the offender received a $200 fine and a suspended sentence.  Maggie’s mother campaigned successfully and in 2003 New Jersey passed a vehicular homicide law.  It made vehicular accidents caused by someone driving without sleep during the preceding 24 hours a felony offense carrying a $100,000 fine and up to 10 years in jail.  To date no other state has passed a vehicular homicide law for driving while drowsy.  Certainly what is fair for the general population is fair for truckers.  An accident where a drowsy auto driver runs into a truck has the same damage and injury potential as one where the trucker hits the auto.  If sleepy driver regulation is not wanted by the general population for themselves, it certainly seems unfair to impose it just on truckers.

Good sleep is extremely important to good health.  Acute lack of sleep causes alterations in physical well being, irritability, mood and overall cognitive functioning, including reduced acuity in controlling a motor vehicle.  Chronic lack of sleep can cause depression, lethargy, fatigue and contribute to numerous morbid medical conditions.  Scientific research has strongly associated sleep apnea with high blood pressure, severely increased risk of heart attack, stroke, diabetes, weight gain, immune system disorders, and reduced sexual libido.  Epidemiologic research has demonstrated that motor vehicle accidents caused by falling asleep at the wheel are more prevalent than those caused by excessive alcohol use.

Unpopular but necessary to address, sleep apnea has more acceptable alternatives than uncomfortable and expensive CPAP machines and uncomfortable, expensive and threatening overnight studies in a sleep lab.  Inexpensive and reliable home sleep studies are available.  Recent guidelines published by the American Academy of Sleep Medicine (Collop et al., 2007) recommend that the same technology used in sleep laboratories be used for unattended portable monitoring in the home.  Such technology includes the use of a thermal oronasal airflow sensor to detect apnea, a nasal airflow cannula to determine hypopnea, respiratory effort belts using respiratory inductive plethysmography technology, pulse oximetry, and body position.  This technology is available today and has been found to be easy to use with high specificity and sensitivity.

In a recent study involving 73 patients comparing the attended sleep laboratory data collection method against the MediByte® unattended portable home monitoring method, Driver et al. (in press) found that the association for the detection of sleep apnea between the two methods were very high: a Pearson correlation of 0.92, accounting for 85% of the variance in the data.  When apnea was moderate to severe, the sensitivity and specificity of the unattended home method was 80% and 97%, respectively.  When the apnea+hypopnea index was greather than 30 times per hour (i.e., severe) the positive predictive value of the MediByte unattended home recorder was 100%, while the negative predictive value was 88%.  The authors concluded that the home recorder accurately identified patients without sleep apnea and had a high sensitivity for moderate to severe apnea patients.

With the aging baby boomer demographics, unattended home sleep apnea testing presents an inexpensive opportunity to increase sleep apnea screening in the USA.  It is also an efficient and convenient technique to evaluate the efficacy of oral appliance therapy.  In most of Europe unattended home sleep testing has been used for many years to economically and reliably diagnose and monitor sleep apnea.  Recent improvements in technology coupled with approval of home sleep testing by the Center for MediCare / MediCaid in 2008 reinforce the view that home sleep testing is a valid and widely accepted option for both diagnosis and monitoring of snoring and sleep apnea.  Now is the time to take advantage of this modern technique to properly address the important issue of sleep apnea diagnosis and management of sleepy drivers.

The diagnosis and treatment of sleep apnea is rapidly approaching critical mass in terms of recent new technological innovations and gaining public awareness.  Numerous intraoral appliances that are FDA approved, and AASM approved for mild to moderate sleep apnea are already being prescribed and fitted by dentists qualified to practice sleep dentistry.  They are comfortable and have a very high compliance rate according to patient testimonials.  Other intraoral sleep apnea devices are in late stage development as comfortable alternatives to CPAP that are both inexpensive and highly effective.    Compliance chips to monitor usage of oral appliances are also in late stage development.  Both technologies, inexpensive intraoral appliances and compliance chips are expected to be available for market by the end of the year.   Collaboration between the trucking industry, the insurance industry, the medical and dental community of interest and the regulatory agencies offer far more affirmative possibilities to make safer roadways than a biased white paper and behind the scenes lobbying efforts by those standing to reap huge financial gain from poorly conceived regulatory mandates.

Allen J. Moses, DDS, Chicago, IL, USA

Richard A. Bonato, PhD, Ottawa, Canada

Three Big Questions

The president of the American Academy of Craniofacial Pain tackles cost, efficacy, and results.

Dentists with experience in sleep medicine hear the same three questions over and over again: 1) Why are oral appliances so expensive?; 2) Are oral appliances ever covered by insurance?; and 3) How do I know if oral appliances are effective? As a fol- low-up to number three, physicians usually want to know why patients they refer for oral appliance therapy rarely, if ever, come back for follow-up.

The fee that most dentists charge—and that most insurance companies pay—usually takes into account everything that dentists do for patients. These services often include x-rays, examinations, treatment planning, dental impressions, and model fabrications. Factor in a laboratory bill for custom appliances (which can be as high as $600), plus fitting and 90-day follow-up, and the typical fee by a dentist who knows what he is doing can be about $2,000 to $3,000.

Jamison Spencer, DMD, MS, president of the American Academy of Craniofacial Pains, knows that sleep physicians don’t always refer to dentists who have extensive experience with oral appliance therapy. “An assumption is often made that all dentists are equally proficient in dental sleep medicine and oral appliances,” says Spencer, a dentist with practices limited to dental sleep medicine and craniofacial pain in Boise, Idaho. “This is absolutely not the case. Dentists receive virtually no education regarding dental sleep medicine in dental school, and many dentists will choose appliances based on dental magazine advertisements rather than education or training.”

Spencer concedes that less experienced dentists may charge a few hundred dollars less than clinicians with hundreds of hours of continuing education, but outcomes will often be less than satisfactory. “I have had many patients referred to my office after being fit with an inferior appliance by a well-meaning dentist who didn’t really understand oral appliance therapy,” laments Spencer. “In the end, the patient pays more than if he had been referred to my office in the first place.”

Sleep physicians are often surprised to learn that oral appli- ance therapy is generally covered by medical insurance, as long as the patient meets criteria for treatment—and Spencer confirms that this criteria is the same as CPAP. While insur- ance coverage usually exists, including through Medicare, most dentists are not aware of how to work with medical in- surance companies or Medicare.

It usually ends up that only dentists who are serious about oral appliance therapy to acquire the knowledge and resourc- es necessary to work with third party payers, Medicare, and Tri- care. Spencer is contracted with many insurance companies, including Medicare and Tricare. He acknowledges that it took years to make it happen.

Sleep docs know the literature regarding oral appliance ther- apy and AASM guidelines. Most are also aware that oral appliances are effective, particularly in mild to moderate OSA. The problem is that patients often do not receive appropriate and objective follow-up.

Once again, this may have to do with whom the sleep doc- tor is sending his patients . Most dentists have their patients’ best interests in mind, but good intentions are not enough. “They usually will not even be aware that their patient should be evaluated in the sleep lab to confirm that the oral appliance is effectively treating the patient’s sleep apnea,” says Spencer. “The only way to know if the oral appliance therapy is work- ing is for the patient is to get back to the sleep lab. While this often requires some patient education, to convince them to go in for yet another sleep study, most patients understand the importance of confirming that the appliance is helping.”

Most insurance companies and Medicare will pay for these follow-up studies, but what about those who don’t have insur- ance coverage, or those who have high deductibles? For these patients, Spencer has developed an oral appliance called the Silent Sleep that is non-custom, but fits in a unique way.

Typical “boil and bite” appliances are difficult to fit, lack retention, are bulky, uncomfortable, and often ineffective. The Silent Sleep is fit using an impression-type material that is odorless, tasteless and durable. “The time for the dentist to fit the appliance is less than 10 minutes, and the complete cost to the dentist is low,” says Spencer. “This is opening up treatment to those who can’t afford CPAP or custom appliances, and is also a great option for those diagnosed as primary snorers.”

Spencer believes that sleep professionals owe it to their pa- tients to coordinate care with dentists who are trained and ex- perienced in dental sleep medicine. A good way to ensure this is for sleep physicians to look for dentists credentialed by the American Academy of Dental Sleep Medicine and the Ameri- can Academy of Craniofacial Pain ( and AACFP. org). These dentists will understand dental sleep medicine, TMJ, and facial pain issues, which is crucial to avoiding and treating possible side effects of oral appliance therapy.

Ultimately, sleep physicians and trained dentists working together can provide effective and affordable treatment op- tions for patients suffering with OSA—including combination therapy where oral appliances are used to help patients to bet- ter tolerate CPAP. Many patients may benefit from oral appli- ance therapy, and the three common concerns can be easily resolved by working with knowledgeable dentists.

“Knowing the facts and seeking answers is the first step,” adds Spencer. “The fact is that oral appliances are reasonably priced considering everything that is included. Medical in- surance will typically cover the therapy, and trained dentists will encourage patients to return to the sleep lab for objective follow up. Knowing these facts will hopefully motivate sleep professionals to find trained dentists to work with.”

In addition to his role as president of the American Academy of Craniofacial Pain, Jamison Spencer, DMD, MS, is a dentist with practices limited to dental sleep medicine and craniofacial pain in Boise, Idaho. He also 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, including helping with the challenges of billing third party payers for payment of oral appliance therapy (