Feasibility and Predictive Accuracy of an In-Home Computer Controlled Mandibular Positioner in Identifying Favorable Candidates for Oral Appliance Therapy

Sleep apnea is a condition in which the throat air passage closes during sleep and repeatedly interrupts breathing. The standard treatment of sleep apnea is air pressure applied to the nose, so-called nasal CPAP, but it is not suitable for all patients. Another treatment is to use a dental appliance while asleep. In this treatment, an appliance covers the upper and lower teeth and acts to pull the jaw forward, which opens the throat passage. This allows the patient to breathe normally. Dental appliance treatment does not work effectively in all patients. In order to identify those in whom dental appliance therapy will be effective, the study sponsor has invented the remotely controlled mandibular positioner, MATRx. The MATRx is an FDA cleared motorized dental appliance which is used overnight in hospital sleep studies and works by pulling the jaw outward under the control of a technician. In order to eliminate the need for an overnight in hospital sleep study, the sponsor has invented a new device that allows for the identification of individuals who are suitable candidates for dental appliance therapy from the comfort of the home. Like with MATRx, participants will sleep with a motorized mandibular positioner in place. But, it is controlled by a computer, rather than a sleep technician, making it a computer controlled mandibular positioner (CCMP). The feasibility and predictive accuracy of multi night testing using the CCMP will be evaluated through participation in this study. The sponsor has carried out two previous research trials leading to the development of the CCMP. The first established the predictive accuracy of the remotely controlled mandibular positioner at identifying candidates suitable for oral appliance therapy and their effective therapeutic setting. The second established the accuracy of the algorithms used by the CCMP to similarly identify successful candidates in a clinical setting. No significant problems were identified in conjunction with