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

Natus Medical Incorporated (Nasdaq:BABY) today 9/16/2011 announced that it has acquired Embla Systems LLC, a leader in the development, manufacturing, and sales of devices used in the diagnosis of sleep apnea. Embla is the largest company in the world focused solely on sleep diagnostics (Polysomnography or PSG and Home Sleep Testing). The company offers a wide spectrum of innovative sleep diagnostic solutions including Embletta home sleep testing devices and three leading PSG platforms: Sandman, REMbrandt, and RemLogic, and Enterprise Sleep Business Management Systems. This breadth of product offerings provides a unique set of tools to help optimize the efficiency of sleep labs.

Natus acquired all outstanding shares of Embla capital stock for $16.1 million in cash, exclusive of direct costs of the acquisition. Embla reported revenue of approximately $30 million for its fiscal year ended December 31, 2010.

Natus expects the acquisition will be accretive to earnings in 2012, adding $0.08 to non-GAAP earnings per share for the year. The non-GAAP results will exclude amortization of acquired intangible assets and potential restructuring and other one-time charges related to the acquisition.

“The Embla acquisition affirms our leadership position in diagnostic neurology products,” said Jim Hawkins, Chief Executive Officer of Natus. “With this acquisition, Natus will now hold the number one position in the worldwide sleep diagnostic market with annual revenue approaching $35 million.”

“Additionally, with approximately 40% of Embla’s revenue coming from international markets, this acquisition positions Natus as the leader in sleep diagnostics outside the United States,” added Hawkins. “More than 100 million people worldwide are suspected to have obstructive sleep apnea. Because of lack of awareness among both patients and physicians more than 80% of those affected remain undiagnosed.”

Natus funded the acquisition through available cash. The purchase price is subject to adjustment based on net working capital as of the purchase date.

Sleep Apnea

Sleep apnea is a sleep disorder characterized by abnormal pauses in breathing or instances of abnormally low breathing during sleep. There are three forms of sleep apnea: central (CSA), obstructive (OSA), and complex or mixed sleep apnea (i.e., a combination of central and obstructive) constituting 0.4%, 84% and 15% of cases respectively. Studies have shown that as many as one in every 15 Americans is affected by at least moderate sleep apnea. One study showed that in middle-age as many as 9% of women and 24% of men were affected, undiagnosed, and untreated. Conditions linked to obstructive sleep apnea include coronary artery disease, congestive heart failure, hypertension, pulmonary hypertension, stroke, and clinical depression, as well as other illnesses including asthma, chronic obstructive pulmonary disease, and diabetes mellitus.

About Embla

Embla Systems began development of medical devices for the detection of sleep apnea beginning in the mid 1990’s. The company has consistently developed innovative products to assist sleep labs in the diagnosis of the condition. In international markets the company is a leader in devices used for sleep studies performed in the patient’s home. With headquarters in Denver, Colorado, the company also has facilities near Buffalo, New York; Ottawa, Ontario, Canada; the Netherlands; and Germany.

Additional information about Embla can be found at http://www.embla.com.

Additional information about Natus Medical can be found at www.natus.com.

SomnoMed MATRx™ and SomnoDent G2 head a rapidly evolving class of oral appliances and overnight study systems that bolster compliance and verify effectiveness.

Executives at Dallas-based SomnoMed (www.somnomed.com) are not afraid of evidence. On the contrary, they are making it easier to objectively measure effectiveness of the company’s oral sleep appliance portfolio. The result is a measure of certainty for sleep physicians who want the best therapy for their patients.

The vehicle that fuels this elusive certainty is the SomnoMed MATRx™ (pending FDA approval). Ralf Barschow, Global CEO of SomnoMed, touts the device as nothing less than a revolutionary breakthrough in the prediction of efficacy for the SomnoDent Mandibular Advancement Splint (MAS).

Responder or Non-Responder?

A typical MATRx scenario usually starts with a SomnoMed dentist taking an oral impression of the patient and fabricating a customized overnight oral appliance. From there, patients take the overnight appliance to a sleep lab where it is used with SomnoMed MATRx.

To conduct a study with SomnoMed MATRx, the overnight appliance is attached to a small motor (50 grams) that is remotely controlled by a sleep technician. “Using this process, sleep technicians can clearly see whether the patient is a responder or non-responder to SomnoDent therapy,” says Barschow, who also serves as president of SomnoMed North America. “The MATRx is analogous to a CPAP titration. For the first time, we are providing a means of predicting whether patients are suitable for an oral appliance. If they are, we can help determine optimal protrusive distance for their SomnoDent once they are returned to their SomnoMed dentist for further titrations.”

MAS Fosters Compliance

Loyal customers are already familiar with SomnoMed’s MAS treatments, each with different clinical indications aimed at OSA sufferers. These include the SomnoDent® Classic, SomnoDent® Flex, and SomnoDent® Edent for the Edentulous patient.

The SomnoDent® MAS is a custom-designed oral device that has been the subject of numerous stringent, independent, evidence-based studies that satisfy the need for safe and effective OSA treatment. The SomnoDent® MAS has a number of design features such as a streamlined design with minimal bulk, which maximizes lingual space, reduces gagging, and offers a comfortable treatment with a compliance rate of over 87% all night (Am J Respir Crit Care Med Vol 163. Pg 1457-1461, 2001).

The company touts an excellent fit in both upper and lower arches with anterior and posterior contact for a stable occlusion, which prevents tooth movement and minimizes temporomandibular joint (TMJ) discomfort and injuries.

The SomnoDent MAS is constructed in two separate pieces that allow patients to open and close their mouth. This allows clear speech, yawning, and drinking without requiring patients to remove the appliance. The ability to communicate clearly while wearing the device is particularly appreciated by patients and their partners.

G2 Builds on Legacy

Building on the considerable legacy of the SomnoDent MAS, Barschow and White introduced the SomnoDent G2 (pending FDA approval) oral appliance at this year’s American Professional Sleep Societies’ (APSS) show in Minneapolis. Like other SomnoDent products, the G2 is made with a proprietary SMH BFlex polymer lining material, which enhances comfort, stability, and durability. “When we launched SomnoDent Flex

2.5 years ago, it was a big surprise in the dental sleep medicine community and raised the quality standard considerably, hence a 3-year manufacturer’s warranty,” says Barschow. “I compare this to our feedback on the next SomnoDent generation G2, which has taken everyone by storm—whether it is the controlled forward protrusion mechanism or the smaller metal-free design.”

“Now for the first time, G2’s proprietary click-on, click-off technology provides certainty and standardization around the titration of an oral appliance,” adds Anthony White, vice president, SomnoMed Marketing & Academy. “This objective measure offers sleep physician’s certainty in prescribing SomnoDent therapy.”

Oral Appliances Here to Stay

Respect for oral appliance therapy remained high at this year’s APSS meeting in Minneapolis, echoing an inevitable trend that only seems to get stronger. Along with greater acceptance, foot traffic around the booth remained high, with serious inquiries outnumbering casual fact finders. “After Seattle and San Antonio, this is the third time we have had a strong presence at APSS,” says White. “The response has been overwhelming. Sleep lab managers and sleep physicians came and said, ‘The MATRx is the missing link here. The ability to prospectively predict which patients would be appropriate for SomnoDent therapy in a polysomno graphic environment means we can, with confidence, provide patients that cannot tolerate or adhere to CPAP a second chance at therapy.”

Bright Future

In many ways, the APSS meeting in Minnesota reflected an industry on the cusp of change. Despite huge patient potential, lesser companies are falling by the wayside.

White believes clinicians will continue to embrace oral appliance sleep apnea therapies, but only patient-focused and evidence-based ideas will succeed. “Our products are backed by independent clinical studies validating their use,” says White. “Once our new products are available, they will all have the necessary medical device approvals and meet all regulatory standards.”

Viewed together, the MATRx (launch expected in Fall of this year) and G2 (release planned for beginning of 2012) are part of SomnoMed’s effort to be viewed as the evidence-based medical device company that provides more than just therapy. Instead, the company is looking for a way to determine efficacy and compliance—all while spreading knowledge. An educational arm called the SomnoMed Academy fosters this mission by generating continuing education credits for the dental and medical fraternity.

Dentists, physicians’ or sleep laboratory officials who wish to get involved can contact the company and purchase a starter program with collateral materials and sample devices. Participating dental professionals may choose to register for a Fundamentals Seminar, which is a 2-day continuing education event. The event is jointly presented by a physician and SomnoMed dentist that teaches dentists how to integrate dental sleep medicine and the SomnoDent therapy in their daily practice. “In accordance with the AASM guidelines, interested dentists learn why and how they need to interact with the medical community to get a proper diagnosis,” says Barschow. “However, we have always maintained, and will continue to maintain, that it is the physician’s role to treat and diagnose the patient. Once the SomnoDent therapy is deemed appropriate treatment, it goes to the dental arena for fitting. Patient care is for the physician, and diagnosis is for the physician.”

Demand for education figures to be high, considering that dental therapy has gained firm acceptance among many segments of the market. It was not too long ago that full PSGs were considered infinitely superior to home tests, just as it was once considered unthinkable that oral appliances could be an equal, or in some cases an even better choice, than CPAP.

Building Confidence

Ultimately, Barschow and White contend that all new products within — must focus on gaining the support and confidence of the patients, dentists, and physicians that will in turn improve crucial compliance rates. “The MATRx and G2 boost confidence among patients and clinicians,” says Barschow, who has more than two decades of experience with dental/medical materials and technology. “Patients are confident they are receiving the highest quality oral appliance treatment out there. That confidence brings them back into treatment, which improves compliance—and improves their lives.”

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For more information, visit  http://www.somnomed.com

The owner of Austin InstaTech carries many CPAP/mask brands, but she favors one brand in particular when it comes to humidification.

As the owner of a DME and sleep lab “with a twist,” Debbie Downey, RRT, RPSGT, works with physicians to -provide their patients with sleep testing and medical equipment as needed. Sleep docs want to know that their patients are being well taken care of, and anything less is bound to mean reduced referrals.

Austin InstaTech is a subcontractor that physicians rely on, and Downey’s experience has taught her that one size does not fit all when it comes to boosting patient compliance. Patients typically are prescribed one of three different types of CPAP, APAP, BiPAP, and masks. “Every patient is different, not one mask fits everyone and not one machine fits all,” she says. “The need for better humidification is a constant. Without it, CPAP can be a miserable experience. For a long time, Fisher & Paykel in particular has preached that humidification matters, and I agree with them.”

As a respiratory therapist, Downey first encountered Calif- based Fisher & Paykel’s humidification technology within the world of ventilators. Similar to its effects in ventilation, efficient humidification wards off excessive drying and swelling. When F&P rolled humidification into PAP therapy, Downey established a relationship with the company that she maintains to this day.

Downey usually opts to put out units with heated humidification and heated tubing if it becomes necessary. “We don’t put out dry PAP devices,” says Downey. “When we have patients with excessive dryness, or excessive reactive mucosa due to dryness, we verify a good mask fit and switch them to the heated tubing to increase humidification.”

ICON Aims for Aesthetics

Fisher & Paykel Healthcare’s ICON is designed to push the aesthetic envelope, while weaving in proprietary ThermoSmart™ technology to match clinical effectiveness with sleek design.

Engineers designed the ICON™ using input culled from in-depth patient and clinician feedback. On the global market for more than a year, the ICON is aiming to capture market share in a highly competitive niche.

When F&P remodeled their PAP device to the ICON platform, Downey gave the unit another look and liked what she saw. “In the past, the F&P design had been rather bulky even though their humidification was elegant,” says Downey. “We have a mobile population these days, and the bigger the CPAP, the less likely it is to travel with the patient on business or vacation. They made the footprint smaller, and patients like that less of their bedside table gets taken up. It is lighter, less cumbersome and the humidifier chamber drops down into the top of the machine, which also makes it easier to use.”

Downey was one of the first sleep professionals in the United States to carry the ICON. According to Masoud Vahidi, senior product manager, Fisher & Paykel, Irvine, Calif, the reception in Australia, New Zealand, and Europe has been enthusiastic. “At CPAPTalk.com, every discussion we have seen has been very positive,” says Vahidi. “Respiratory therapists and sleep technicians are wowed. We, as well as our customers, get daily calls from patients asking when ICON is going to be available, so there is great excitement.”

Clinicians have embraced the ICON’s ThermoSmart™ technology which mimics the ability of the nose to heat and humidify the air to prevent symptoms such as dryness and congestion caused by CPAP use. A recent bench study found that ThermoSmart™ delivered average absolute humidity levels greater than 27 mg/L, and without causing condensation.¹

Appealing to Patients

With neutral colors, Vahidi believes the ICON can discreetly blend into the bedroom environment. Since it also comes with full digital clock and alarm capabilities, it can free up limited space on the nightstand.

Downey initially pegged the digital clock and alarm additions as non therapeutic “hooey,” but now she admits with a chuckle that it was a good idea. “In Austin, Texas, we have a lot of 30-something guys who come in for CPAP therapy, and it’s not very sexy,” she says. “You have the ability to download music to the ICON. It’s not a therapeutic thing, but this type of ‘cool technology’ makes it more approachable to them. I did not think it would be popular, but when I tell them they can download different ring tones and alarm tones, it’s a feature they like. If it can boost compliance, I am for it. It goes to show that it is not always about therapeutic applications.”

“The ICON will fit in well in a patient’s bedroom,” adds Vahidi. “It has a forward facing display and a clock that blends in well. If you look at what people usually have on their nightstand— a radio, clock, phone, a book—the ICON fits right in and replaces the need for a clock. In the past, many patients have felt uncomfortable being on CPAP therapy and elected to take their CPAP units off the nightstand and hide it underneath the bed while not in use. With the ICON, they can feel comfortable leaving it out.”

The high-tech look goes well with a computer-driven interactivity that features more menus that patients can access. The menus provide familiar ways for patients to look at data and get feedback on how they are doing with the therapy. “In this day and age, where patients are relatively computer savvy, this can be really helpful,” enthuses Downey. “When you tell patients they can turn to this menu and see how many apneas they had last night they can correlate that to the type of mask they were using, because that might affect results.

What were the circumstances in the home that may have changed the numbers?”

Feedback allows patients to become active participants in their care. “Instead of guessing, they have empirical data that is right there on the screen,” says Downey. “You give patients some measure of control, and they know we want a certain number. They become more compliant, accepting more responsibility for therapy outcomes.”

Ultimately, Downey evaluates every new advance based on the holy grail of compliance and therapeutic results. She appreciates the ICON’s improved ability to allow a greater range of internal temperature settings for heated humidification, a feature that allows her to bracket low, medium, and high temperature ranges. If patients don’t get enough humidity, they can choose a low, medium, or high temperature range.

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1 Virag R. Evaluation of the performance of CPAP heated humidifiers for use in sleep apnea therapy: a comparative study of humidification effectiveness Sleep 2008; 31: A382.

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.

Cost
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.”

Coverage
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.

Efficacy
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 (AADSM.org 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 (www.ctisleep.com).