Randomized trial compares mandibular jaw movement monitoring with polysomnography for obstructive sleep apnea diagnosis, suggesting effective alternative.
Key Points
This trial aims to evaluate the effectiveness of an AI-supported device for diagnosing obstructive sleep apnea (OSA) compared to traditional methods.
Multicenter, randomized, controlled, open-label design conducted in France from October 2021 to October 2024.
Adults aged 18-80 years with suspected OSA were randomized to receive either mandibular jaw movement monitoring or polysomnography for diagnosis.
Primary endpoints included time to diagnosis and treatment, and changes in daytime sleepiness at 3 months post-diagnosis.
Median time to diagnosis was significantly shorter with mandibular jaw movement analysis (15 days) compared to polysomnography (106 days) both with p < 0.01.
MJM-based diagnosis noninferior to PSG in reducing daytime sleepiness at 3 months (-2.26 vs. -2.29; 95% CI -0.85, 0.79).
Superior daytime sleepiness improvement at 3 months post-randomization with MJM analysis (difference: -1.51; p < 0.01).