Background: The purpose of this study was to evaluate the effectiveness of mandibular advancement devices (MADs) for treatment of obstructive sleep apnea syndrome (OSAS) compared with the results obtained with a placebo device in accordance with the following indicators: apnea hypopnea index (AHI) per hour of sleep, apnea index (AI) per hour of sleep, mean oxyhemoglobin saturation, sleep efficiency, and percentage of rapid eye movement (REM) sleep.
Methods: This is a controlled, prospective longitudinal study with a follow-up time of 10.5 months. Nineteen patients (8 females and 11 males) with mean age 48.6 years (SD 9.6) were selected for the study. The sample was randomized in terms of device use, and the evaluation design was double blind. A total of 57 polysomnography tests were studied (at baseline, after the use of a MAD, and after the use of placebo). The following variables were assessed: AHI, AI, mean oxyhemoglobin saturation, percentage of REM sleep, and sleep efficiency. Wilcoxon and Mann-Whitney tests were used for evaluating data (p<0.05).
Results: Reductions from 16.3 to 11.7 in AHI and from 5.7 to 3.8 in AI were observed after MAD use. During the use of placebo, AHI increased from 16.3 to 19.6, and AI from 5.7 to 7.5. The other indexes showed no statistically significant differences.
Conclusions: Treatment with oral appliances, i.e., MADs, can be an effective alternative for mild and medium-to-moderate OSAS, but requires strict monitoring due to differences in individual response to this therapy.