Objectives/Goals: Both mandibular advancement device (MAD) and hypoglossal nerve stimulation surgery (HGNS) are accepted options for positive airway pressure (PAP) intolerant OSA, yet decisions rely more on preference than evidence. We ask whether MAD is an effective alternative to HGNS for adults with moderate-to-severe OSA who have failed PAP. Methods/Study Population: In this single institution, nonrandomized clinical trial in adults with moderate-to-severe OSA (3% AHI 15-65) who failed, declined, or are intolerant to PAP were assessed for eligibility starting June 2025. Patients with BMI>40, prior MAD failure, or chronic nasal obstruction were excluded. PAP-intolerant patients from the WashU Sleep Center and ENT clinics were offered MAD ( N = 30) and compared with propensity score-matched patients scheduled for HGNS at the same center ( N = 30). Follow-up data will be collected 4 weeks after treatment (MAD) or post-titration (HGNS). Planned analyses will control for baseline differences and other factors associated with outcomes. Results/Anticipated Results: We will capture the change in baseline and post-intervention patient-reported outcome measures (PROMs) and sleep metrics to compare treatment efficacy. PROMs include: the Pittsburgh Sleep Quality Index (primary outcome), Epworth Sleepiness Scale, and SNORE-25 for OSA-related quality of life. Sleep metrics include AHI, oxygen desaturation Index, and modified Sher criteria. Data on adherence, tolerability, treatment satisfaction, and adverse events will also be collected. To date, we have enrolled 19 of 60 participants. Discussion/Significance of Impact: This study will estimate the magnitude of the difference in the change in PROMs and sleep study outcomes between MAD and HGNS. Findings may guide post-PAP treatment selection, inform payer coverage for MAD therapy, and provide data for a follow-up RCT.
Jama et al. (2026) studied this question.