Objective: To compare the effectiveness of positional therapy (PT) with the sleep position trainer (SPT) to oral appliance therapy (OAT) in patients with mild-to-moderate positional obstructive sleep apnea (POSA).
Methods: Multicenter, prospective, randomized, controlled trial. Patients with mild-to-moderate POSA (apnea-hypopnea index (AHI) ≥5 ≤ 30/hour sleep) were randomized for PT or OAT. Polysomnography was repeated after 3 months. Efficacy, adherence, mean disease alleviation (MDA), quality of life, dropouts and adverse events were evaluated.
Results: A total of 177 patients were screened for the study; 99 underwent randomization and 81 completed the study. Intention-to-treat (ITT) analysis of median [IQR] AHI showed a reduction in the PT group from 13.0 [9.7-18.5] to 7.0 [3.8-12.8], p < 0.001 and in the OAT group from 11.7 [9.0-16.2] to 9.1 [4.9-11.7], p < 0.001. Mean adherence (≥4 h/night, ≥5 days/week) was 89.3 ± 22.4% for SPT versus 81.3 ± 30.0% in OAT patients, p = 0.208.
Conclusions: Oral appliance therapy and positional therapy were equally effective in reducing the median AHI in patients with mild-to-moderate POSA. The results of this study have important implications for future OSA treatment guidelines and daily clinical practice. CLINICALTRIALS.
Gov number: NCT02045576.
Keywords: Obstructive sleep apnea; Oral appliances; Positional obstructive sleep apnea; Positional therapy; Randomized, controlled trial.
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