Effect of orofacial myofunctional therapy with auto-monitoring on the apnea-hypopnea index in patients with mild-to-moderate obstructive sleep apnea: a multicenter randomized controlled trial.
Diana Dobran Hansen, Unn Tinbod, Xin Feng et al.
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In 30 seconds
This multicenter randomized controlled trial assessed standardized orofacial myofunctional therapy (OMT) in treatment-naive adults with mild-to-moderate obstructive sleep apnea. Participants received 12 weeks of OMT or were assigned to a waitlist control, with sleep outcomes measured before and after treatment. In the intention-to-treat analysis of 104 participants, OMT did not significantly affect apnea-hypopnea index (AHI): the between-group difference in AHI change was 0.6 (95% CI -3.3 to 4.5; P = .774). Desaturation measures and Epworth Sleepiness Scale scores also showed no detected change.
Key findings
- Among 104 participants, the between-group difference in AHI change was 0.6 (95% CI -3.3 to 4.5; P = .774).
- Mean adherence was 64.6% (95% CI 61.0 to 76.8), and higher adherence was not significantly associated with greater AHI reduction (β = -0.1, 95% CI -0.2 to 0.1; P = .353).
- No change was detected in desaturation measures or Epworth Sleepiness Scale scores.
Why it matters
The trial provides controlled evidence on a standardized OMT protocol, an intervention considered as a non-invasive option for OSA. Its null findings temper expectations that this 12-week protocol improves AHI, oxygen desaturation outcomes, or sleepiness in treatment-naive adults with mild-to-moderate disease. The results also underscore the value of evaluating proposed therapies with prespecified outcomes and rigorous trial designs.
What to keep in mind
The intervention and follow-up were limited to 12 weeks, so the study does not establish longer-term effects or effects of other OMT protocols or patient subgroups.