Oral appliance therapy versus nasal continuous positive airway pressure in obstructive sleep apnea: a randomized, placebo-controlled trial.

ABSTRACT

BACKGROUND: Previous randomized controlled trials have addressed the efficacy of mandibular advancement devices (MADs) in the treatment of obstructive sleep apnea (OSA). Their common control condition, nasal continuous positive airway pressure (nCPAP), was frequently found to be superior to MAD therapy. However, in most of these studies, only nCPAP was titrated objectively but not MAD. To enable an unbiased comparison between both treatment modalities, the MAD should be titrated objectively as well. OBJECTIVE: The aim of the present study was to compare the treatment effects of a titrated MAD with those of nCPAP and an intra-oral placebo device. METHODS: Sixty-four mild/moderate patients with obstructive sleep apnea (OSA; 52.0 ± 9.6 years) were randomly assigned to three parallel groups MAD, nCPAP and placebo device. From all patients, two polysomnographic recordings were obtained at the hospital one before treatment and one after approximately 6 months of treatment. RESULTS: The change in the apnea-hypopnea index (ΔAHI) between baseline and therapy evaluation differed significantly between the three therapy groups (ANCOVA; p = 0.000). No differences in the ΔAHI were found between the MAD and nCPAP therapy (p = 0.092), whereas the changes in AHI in these groups were significantly larger than those in the placebo group (p = 0.000 and 0.002, respectively). CONCLUSION: There is no clinically relevant difference between MAD and nCPAP in the treatment of mild/moderate OSA when both treatment modalities are titrated objectively.