Study Objectives: Mandibular protruding oral appliances represent a potentially important therapy for obstructive sleep apnea (OSA). However, their clinical utility is limited by a less-than-ideal efficacy rate and uncertainty regarding an efficacious mandibular position, pointing to the need for a tool to assist in delivery of the therapy. The current study assesses the ability to prospectively identify therapeutic responders and determine an efficacious mandibular position. Methods: Individuals (n = 202) with OSA participated in a blinded, 2-part investigation. A system for identifying therapeutic responders was developed in part 1 (n = 149); the predictive accuracy of this system was prospectively evaluated on a new population in part 2 (n = 53). Each participant underwent a 2-night, in-home feedback-controlled mandibular positioner (FCMP) test, followed by treatment with a custom oral appliance and an outcome study with the oral appliance in place. A machine learning classification system was trained to predict therapeutic outcome on data obtained from FCMP studies on part 1 participants. The accuracy of this trained system was then evaluated on part 2 participants by examining the agreement between prospectively predicted outcome and observed outcome. A predicted efficacious mandibular position was derived from each FCMP study. Results: Predictive accuracy was as follows: sensitivity 85%; specificity 93%; positive predictive value 97%; and negative predictive value 72%. Of participants correctly predicted to respond to therapy, the predicted mandibular protrusive position proved efficacious in 86% of cases. Conclusions: An unattended, in-home FCMP test prospectively identifies individuals with OSA who will respond to oral appliance therapy and provides an efficacious mandibular position. Clinical Trial Registration: The trial that this study reports on is registered on www.clinicaltrials.gov, ID NCT03011762, study name: Feasibility and Predictive Accuracy of an In-Home Computer Controlled Mandibular Positioner in Identifying Favourable Candidates for Oral Appliance Therapy Keywords: home sleep test, obstructive sleep apnea, oral appliance therapy, predictive accuracy, sleep-disordered breathing Citation: Remmers JE, Topor Z, Grosse J, Vranjes N, Mosca EV, Brant R, Bruehlmann S, Charkhandeh S, Jahromi SA. A feedback-controlled mandibular positioner identifies individuals with sleep apnea who will respond to oral appliance therapy. J Clin Sleep Med. 2017;13(7):871-880.
I NTRO DUCTI O NObstructive sleep apnea (OSA) is a chronic disease caused by repeated narrowing or closure of the pharynx during sleep. The disease compromises quality of life, 1,2 increases risk of accidents, [3][4][5] and is associated with an increased risk of cardiovascular events 6 and reduced survival rate. 7,8 Continuous positive airway pressure (CPAP), the standard therapy for this disease, is efficacious and benign. However, long-term compliance with CPAP is low, 9,10 and this may contribute to its ineffectiveness in preventing adverse...