Treatment, airway and compliance effects of a titratable oral appliance

Study Objectives: To measure the effects of a titratable anterior mandibula r repositioner on airway size and Obstructive Sleep Apnea (OSA) and to eval uate its compliance. Design: Before and after insertion sleep studies were obtained in a total o f 38 OSA patients of varying severity from three different sites. Covert co mpliance was measured by means of a newly-developed, miniaturized, temperat ure-sensitive, imbedded monitor. Validity testing was completed in six adul t volunteers who wore monitors imbedded into small acrylic appliances. Measurements and Results: The mean RDI before treatment was 32.6 (SEM 2.1) and after the insertion of the appliance, the RDI was reduced to 12.1 (SEM 1.7, p<0.001). RDI was reduced to less than 15/hour in 80% of a group of mo derate OSA patients (RDI 15 to 30) and in 61% of a group of severe OSA pati ents (RDI > 30) with respect to baseline RDI. Fiber optic video endoscopy w as performed on 9 OSA patients with and without the appliance. No significa nt differences in hypopharynx or oropharynx cross sectional areas were foun d, but at the level of the velopharynx, the airway size was significantly i ncreased (p<0.05). The index of agreement was 0.99 between the monitor cloc k time and the subject's log sheets. Compliance data from eight OSA subject s instructed to wear the appliance during sleep indicated that it was worn for a mean of 6.8 hours with a range of 5.6 to 7.5 hours per night. Conclusion: The titratable adjustable mandibular advancement appliance, mad e from thermoelastic acrylic, significantly reduces RDI in moderate to seve re OSA patients, has a direct effect on airway size and is well worn throug hout the night.