Comprehensive Oral Appliance Treatment For Sleep Apnea

Obstructive sleep apnea occurs when people choke on their tongues during sleep. Dentists make a variety of different oral appliances to treat obstructive sleep apnea, and they are tolerated by patients much better than CPAP; but they almost all work just by advancing the mandible (the lower jawbone).  Advancing the mandible creates space in front of the tongue and thereby allows it to rest in a more forward (advanced) position; but advancing the mandible cannot draw the tongue forward into that new space, because the tongue and mandible are only attached by muscles, which naturally lose most of their tonus during sleep. As a result, they only cure the problem in half of the patients treated.

To relieve sleep apnea in the people with ineffective mandibular advancement appliances and in people who wear dentures, Dr. Summer has developed new technologies that can be added to these oral appliances to also control the soft tissues that produce the actual obstruction. A tongue holding device holds the tongue and tongue base forward together with the mandible so it cannot drop back into the pharynx, while a soft palate elevator draws the end of the soft palate forward and upward away from obstruction in the nasopharynx.  These components are described in detail along with the rationale and pathoplysiology of sleep apnea, written carefully and accurately for dentists and doctors treating sleep apnea, in the file entitled, MULTI-LEVEL TREAMENT OF OBSTRUCTIVE SLEEP APNEA under the tab FOR DOCTORS.  

THE TONGUE HOLDING DEVICE grasps the tongue between thousands of tiny forward slanted bristles that prevent it from dropping back into the pharynx. They hold the tongue with its tip between the incisors and the lips closed around the tongue tip - the target tongue position. The upper and lower tongue gripping surfaces are gently squeezed around the tongue by means of a light spring that produces a cushioned grip which ensures comfort and prevents accidental tongue release when moving the jaw around like during nocturnal bruxism. The tongue cannot slip out until the patient opens wide to activate the tongue release mechanism. The oral appliance carrying the tongue gripping surfaces contains bite stops to ensure that the patient can bite down with full strength without hurting the tongue. 

The first pilot study for the FDA submission used patients with a normal healthy set of teeth (dentate patients).  The 2025-2026 study will involve only denture patients who have obstructive sleep apnea. They will receive a new denture baseplate (no teeth) containing a tongue holding device and also a soft palate elevator if needed.  Multi-night home sleep testing will be used to guide treatment.  

THE SOFT PALATE ELEVATOR, which has already been cleared by the FDA, uses a soft silicone bulb on the end of a thin flat sheet metal arm to raise the center of the soft palate, where there are no gag reflexes, to draw forward the back end of the soft palate, which is so full of gag reflexes that it cannot be contacted directly. The flexible arm allows it to move up and down with the normal action of the soft palate during swallowing, when breathing stops anyway. Most people don't even know it's there. A soft palate elevator can be added to most upper oral appliances to eliminate snoring, because the soft palate is the area that usually vibrates to produce snoring. It also can help prevent sleep apnea by pulling the back end of the soft palate out of the narrow space between the tongue base and the pharyngeal wall, where it acts like a gasket to stop the airway flow.