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Orofacial Myofunctional Therapy and Positive Airway Pressure-CPAP Trial for Mild-to-Moderate Obstructive Sleep Apnea
Sponsor: Saint-Joseph University
Summary
The goal of this clinical trial is to evaluate the isolated and combined effects of orofacial myofunctional therapy (OMT) and continuous positive airway pressure (CPAP) in adults with mild-to-moderate obstructive sleep apnea. The main questions it aims to answer are whether OMT alone, CPAP alone, or combined OMT plus CPAP improves obstructive sleep apnea severity at Week 12, as measured by the apnea-hypopnea index (AHI), and whether these interventions improve mandibular excursion. Researchers will compare 4 groups-sham plus standard of care, OMT plus standard of care, CPAP plus standard of care, and combined OMT plus CPAP plus standard of care-to assess differences in respiratory and anatomical-functional outcomes. Participants will be randomized to 1 of the 4 study arms. During the 12-week supervised intervention phase, participants will receive their assigned intervention together with standardized sleep-hygiene and lifestyle counseling. Assessments include sleep recording, mandibular excursion measurements, questionnaires on sleepiness and sleep quality, dento-occlusal and anthropometric measurements, and treatment adherence monitoring. After Week 12, participants will enter an observational follow-up phase through Week 52 to evaluate durability of treatment effects, treatment persistence, symptom recurrence, and clinically indicated treatment modifications.
Official title: Isolated and Combined Effects of Orofacial Myofunctional Therapy and Continuous Positive Airway Pressure on the Apnea-Hypopnea Index and Mandibular Excursion in Adults With Mild-to-Moderate Obstructive Sleep Apnea: The OMPACT-OSA Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
168
Start Date
2026-05
Completion Date
2028-05
Last Updated
2026-04-20
Healthy Volunteers
No
Conditions
Interventions
Sham Breathing Sessions
Placebo breathing sessions delivered with the same frequency of visits and reminders as the active orofacial myofunctional therapy arm.
Orofacial Myofunctional Therapy
Structured orofacial myofunctional therapy program delivered over 12 weeks, consisting of 3 sessions per day of approximately 8 minutes each. Participants assigned to OMT will receive a 30-minute training session delivered by a speech therapist, either face-to-face or via videoconference. Training includes exercise demonstration, guided practice, posture correction, and access to PDF handouts and instructional videos. Adherence will be monitored primarily using the Loop Habit Tracker application configured for 3 daily reminders; a paper logbook will be used when digital tracking is not feasible. Reinforcement messages will be sent every 48 hours, and a Day-30 videoconference will be conducted to review technique and troubleshoot barriers.
Continuous Positive Airway Pressure
Participants assigned to CPAP will receive a Week-1 telephone call to confirm installation and resolve technical issues, and a Week-6 adherence support visit to optimize mask fit and encourage use. Device-derived adherence metrics will include mean nightly use, P90/P95 pressure, median pressure, and mask leak statistics.
Standard of Care Sleep-Hygiene and Lifestyle Counseling
Standardized sleep-hygiene counseling and general non-pharmacological lifestyle recommendations provided uniformly to all participants, including regular sleep-wake schedules, avoidance of alcohol and sedatives before bedtime, reduction of evening screen exposure, optimization of the sleep environment, and encouragement of healthy dietary habits and physical activity aimed at gradual weight control.