The CPAP Alternative – Oral Appliance Therapy

There are only two therapies recommended by the American Academy of Sleep Medicine for the treatment of obstructive sleep apnea: continuous positive airway pressure (CPAP) and oral appliance therapy (OAT). Appliances used in oral appliance therapy must be FDA 510 K “approved” for the treatment of obstructive sleep apnea. To acquire FDA “approval” of a medical device the applicant must provide reasonable assurance of the device’s safety and effectiveness. These CPAP alternatives are custom-made by prescription only and fitted by a doctor to each individual’s unique anatomy. The prefabricated (one size fits all); thermoplastic (boil & bite) appliances you see advertised on T.V. and the internet are only “cleared” by the FDA to treat snoring, not obstructive sleep apnea. To acquire FDA “clearance” to market a device the applicant must show that it is “substantially equivalent” to a device that is already legally marketed for the same use, in this case snoring only.

The conclusion of a study published in the American Journal of Respiratory and Critical Care Medicine, VOL. 178 2008, stated:

“In conclusion, this randomized controlled cross-over trial provides primary evidence that a custom-made appliance is more efficacious than a prefabricated appliance made from thermoplastic material in the treatment of snoring and mild sleep apnea. In addition, on the basis of these results, a screening trial with a prefabricated appliance that is directly fitted intra-orally cannot be recommended as a convenient low-cost screening strategy to predict success with custom-made appliances.”

Like any precision medical instrument, knowledge and experience is required in their construction, placement and adjustment in order to be successful. They are handmade to exacting specifications only by licensed laboratories. Custom-made prescription oral appliances are associated with much higher compliance rates than CPAP for the majority of patients, especially when provided by credentialed but more importantly, experienced practitioners.

The CPAP Alternative

Oral appliance therapy provided by dental sleep medicine specialists trained in the use of these devices can be an effective alternative to CPAP.

A “Practice Parameters” report published on February 1, 2006 by the American Academy of Sleep Medicine in their journal Sleep (Volume 29, Number 2) stated that:

“Oral appliances (OA’s) are indicated for use in patients with mild to moderate OSA who prefer them to continuous positive airway pressure (CPAP) therapy, or who do not respond to, are not appropriate candidates for, or who fail treatment attempts with CPAP. Until there is higher quality evidence to suggest efficacy, CPAP is indicated whenever possible for patients with severe OSA before considering OA’s. Oral appliances should be fitted by qualified dental personnel who are trained and experienced in the overall care of oral health, the temporomandibular joint, dental occlusion and associated oral structures.”

There are no surgeries recommended by the American Academy of Sleep Medicine for the treatment of obstructive sleep apnea, due to very low published success rates. Oral appliance therapy is the only recommended CPAP alternative.

Advantages of Oral Appliance Therapy

Oral appliance therapy has many advantages over other forms of therapy:

• Oral appliances are comfortable and easy to wear. Most people find that it only takes a couple of weeks to become acclimated to wearing the appliance.
• Oral appliances are small and convenient, fits in a pocket or “carry-on” making them easy to get through airport security and wear on those long international flights.
• You can sleep in any position.
• Romance is back in the bedroom.
• No noise and no sores/ marks on your face.
• Doesn’t need electricity – You can go camping, hunting and fishing.
• Discreet – No one has to know. You can share hotel rooms and stay with the grandchildren again.
• Treatment with oral appliances is clinically proven, reversible, non-surgical and non-invasive.

In a published survey, oral appliance users reported their treatment:

ACCEPTED: 96% reported would likely continue use.
EFFECTIVE: 91% reported improved sleep quality.
COMPLIANT: 88% reported nightly use.