J Clin Sleep Med. 2026 Nov 10;22(1):221. doi: 10.1007/s44470-026-00229-x.
ABSTRACT
PURPOSE: Orofacial myofunctional therapy (OMT) is a promising treatment for obstructive sleep apnea (OSA), but protocols vary and outcomes are inconsistent. The primary aim was to evaluate the effect of a standardized OMT protocol on changes in apnea-hypopnea index (AHI). Secondary aims were to analyze associations between OMT adherence and change in objective and self-reported outcomes.
METHODS: Treatment-naive adults with mild-to-moderate OSA were randomized in a multicenter trial to 12 weeks of OMT or a waitlist control group. Three nights of polysomnography were completed before and after the intervention. Adherence was registered electronically. The primary outcome was change in AHI. Pre-defined secondary outcomes were changes in desaturation measures and in the Epworth Sleepiness Scale (ESS) score. Intention-to-treat analyses were performed using linear mixed-effects models, whereas per-protocol analyses were based on analysis of covariance.
RESULTS: A total of 104 participants (mean age 47.1 ± 12.2 years) were included. Intention-to-treat analysis included 104 participants (52 treatment, 52 waitlist) and showed no significant effect of OMT on AHI. Difference in AHI change between groups was 0.6 (95% CI -3.3 to 4.5; P = .774). Overall mean adherence across all days and participants was 64.6% (95% CI 61.0 to 76.8). Higher adherence was not associated with significantly greater reduction in AHI (β = -0.1, 95% CI -0.2 to 0.1; P = .353). No change was detected in pre-defined secondary outcomes.
CONCLUSION: Twelve weeks of standardized OMT had no significant effect on AHI, desaturation measures or ESS score in treatment-naive patients newly diagnosed with OSA.
CURRENT KNOWLEDGE/STUDY RATIONALE: Orofacial myofunctional therapy (OMT) is increasingly considered a non-invasive treatment for obstructive sleep apnea (OSA), but existing evidence is heterogeneous and often limited by methodological shortcomings. We therefore conducted a randomized controlled trial to evaluate the effects of a standardized OMT protocol in adults newly diagnosed with mild-to-moderate OSA.
STUDY IMPACT: The intervention did not improve pre-defined OSA outcomes, highlighting the importance of rigorous trials even when results are negative. These findings help refine the evidence base for OMT in adults with OSA while supporting continued investigation of alternative protocols and populations stratified by endo- or phenotyping.
TRIAL REGISTRATION: Registry: ClinicalTrials.gov, Identifier: NCT06079073, URL: https://clinicaltrials.gov/study/NCT06079073 , First submission: 2023-08-23.
PMID:43009707 | DOI:10.1007/s44470-026-00229-x
