Objective: To assess the efficacy and compliance of a traction-based mandibular repositioning device (MRD) for treatment of moderate to severe obstructive sleep apnea syndrome (OSAS) under a patient-driven protocol in a routine outpatient care setting.
Methods: Forty patients, 10 severe and 30 moderate OSAS sufferers (apnea-hypopnea index [AHI] >30 and between 15 and 30, respectively), were enrolled by four sleep centers. Nocturnal polygraphy, quality of life, and quality of sleep questionnaires were used to measure the effect of treatment after 45 days.
Results: Thirty-five patients completed the study. Frequency of respiratory events, daytime sleepiness, snoring, patient assessment of sleep quality, specific short-form multipurpose health survey (SF-36) and the Pittsburgh Sleep Quality Index (PSQI) improved significantly with the MRD. Sixty percent of patients were "responders" (>50% decrease in AHI); 46% of patients were "full responders" (>50% decrease and AHI <10). Observance of treatment was high; 80% of patients wore the MRD every night. Side effects and patient complaints were minor and transitory. No serious side effects or cases of pathology aggravation were reported.
Conclusion: Efficacy on respiratory and somnolence parameters of this innovative traction-based MRD was validated under a simple protocol of care with response rates similar to those published in the literature. This study shows consistent significant improvement by the MRD in quality of life and quality of sleep parameters across several tests. Treatment with the MRD under a simple, patient-driven protocol of care with control of efficacy by nocturnal polygraphy is appropriate in routine outpatient practice for moderate OSAS patients.