Effect of Orofacial Myofunctional Therapy with Auto-Monitoring on the Apnea–Hypopnea Index and Secondary Outcomes in Treatment-Naïve Patients with Mild to Moderate Obstructive Sleep Apnea (OMTaOSA): A Multicenter Randomized Controlled Trial Protocol

Background: The aim of this article is to describe the protocol of a large, multicenter randomized controlled trial evaluating the effects of orofacial myofunctional therapy with auto-monitoring (OMTa) versus auto-monitoring alone on obstructive sleep apnea (OSA) assessed by the apnea–hypopnea index and other pre-specified outcomes. Method: The OMTaOSA study protocol was registered at ClinicalTrials.gov (NCT06079073) in August 2023, and data collection ended in January 2025. One hundred and four participants with mild and moderate OSA were included. Randomization was conducted in a 1:1 ratio, using sex-stratified blocks. The intervention was a standardized protocol of OMT exercises previously shown to be effective, auto-monitoring with a Withings scan watch, and feedback from self-reports. Controls received watches and access to the same application without the exercise module. Sleep was measured over three nights at baseline and after three months. The sleep scorer and researchers evaluating other outcomes were blinded to the treatment allocation. Change in the apnea–hypopnea index was defined as the primary outcome. Secondary outcomes are published on Clinicaltrials.gov. Results: The results of the trial are still in preparation. Conclusions: By addressing the limitations of previous OMT studies, this trial may clarify the effectiveness of digitally delivered OMT for patients with mild to moderate OSA.