Study objectives: To measure the effects of a titratable anterior mandibular repositioner on airway size and Obstructive Sleep Apnea (OSA) and to evaluate its compliance.
Design: Before and after insertion sleep studies were obtained in a total of 38 OSA patients of varying severity from three different sites. Covert compliance was measured by means of a newly-developed, miniaturized, temperature-sensitive, imbedded monitor. Validity testing was completed in six adult 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 moderate OSA patients (RDI 15 to 30) and in 61% of a group of severe OSA patients (RDI > 30) with respect to baseline RDI. Fiber optic video endoscopy was performed on 9 OSA patients with and without the appliance. No significant differences in hypopharynx or oropharynx cross sectional areas were found, but at the level of the velopharynx, the airway size was significantly increased (p<0.05). The index of agreement was 0.99 between the monitor clock time and the subject's log sheets. Compliance data from eight OSA subjects 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, made from thermoelastic acrylic, significantly reduces RDI in moderate to severe OSA patients, has a direct effect on airway size and is well worn throughout the night.