A prospective, non-randomized sequential study published in the American Journal of Respiratory and Critical Care Medicine reports that mandibular advancement device (MAD) therapy achieves non-inferior clinical effectiveness compared with continuous positive airway pressure (CPAP) in moderate-to-severe obstructive sleep apnea (OSA). The primary outcome — mean disease alleviation (MDA), a composite of efficacy and adherence — favored MAD numerically but did not reach statistical significance for inferiority. However, the authors caution that the sequential design and unvalidated primary endpoint limit whether the findings establish clinical non-inferiority.
Mandibular advancement devices proved non-inferior to CPAP in a combined measure of efficacy and adherence (MDA) after 3 months of each therapy in a sequential crossover-like study.
Nightly adherence was significantly higher with MAD (6.7 vs. 5.4 hours/night), and more patients expressed preference for MAD (51% vs. 42%).
CPAP achieved greater AHI reduction (median 4.1 vs. 8.4 events/hour), but the difference did not undermine non-inferiority on the primary endpoint.
The study's sequential, non-randomized design and lack of validation of the MDA composite against long-term patient outcomes mean that results should be interpreted cautiously until confirmed in randomized trials.
