Prospective evaluation of an oral appliance in the treatment of obstructive sleep apnea syndrome.

The purpose of this study was to investigate the effects of an oral appliance (OA), with and without mandible advance, in the treatment of obstructive sleep apnea syndrome (OSA). Twenty-four patients diagnosed with OSA agreed to participate in this study. The patients were treated for 3 months (with a removable soft elastic silicone positioner customized with thermoplastic silicone and with a 5-mm opening). Patients were selected, using a randomized design, to receive an OA model either with (12 patients) or without advance (12 patients). Before treatment, a snoring questionnaire, the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), the Functional Outcomes of Sleep Questionnaire (FOSQ), the Epworth Sleepiness Scale (ESS), and polysomnography were completed. Fifteen subjects completed the protocol (13 men, two women). With respect to basal values, the mandible-advanced OA group presented a decrease in the mean apnea-hypopnea index (AHI) (33.8+/-4.7 versus 9.6+/-2.1; p<0.01), number of arousals per hour (33.8+/-13.9 versus 16.0+/-1.5; p<0.05), ESS score (14.7+/-5.1 versus 5.1+/-1.9; p<0.05), snoring score (15.4+/-1.9 versus 10.1+/-3.2; p<0.05), and total FOSQ score (78.1+/-22.6 versus 99.3+/-14.4; p<0.05). After treatment, the non-advanced group presented a decrease in the mean AHI (24.0+/-12.2 versus. 11.7+/-7.9; p<0.05). However, no significant differences were found in the number of arousals per hour, ESS score, snoring, and total FOSQ score in the non-advanced group. Neither study group showed significant difference in mean SF36 scores. Oral appliances, especially those that advance the mandible, offer an effective treatment for OSA.

RCT Entities:   Population Interventions Outcomes