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.
Age 18 years or older.
Mild-to-moderate OSA (AHI 5.0-29.9 events/hour) confirmed by Type I polysomnography.
Protrusive excursion of at least 5 mm measured with the George Gauge.
No previous treatment with CPAP or OMT.
Severe obstructive sleep apnea (AHI 30 events/hour or higher) or urgent need for CPAP
Suspected or confirmed obesity hypoventilation syndrome, chronic ventilatory failure, or severe obesity associated with daytime hypercapnia or hypoxemia
Clinically significant insomnia, defined as an Insomnia Severity Index (ISI) score > 14 at screening.
Uncontrolled psychiatric or neurological conditions likely to substantially affect sleep quality or daytime symptoms independently of OSA (e.g., major depressive episode, severe anxiety disorder, chronic disabling migraine)., as judged by the investigator.
Factorial
Sham Breathing Sessions
BehavioralPlacebo breathing sessions delivered with the same frequency of visits and reminders as the active orofacial myofunctional therapy arm.
Orofacial Myofunctional Therapy
BehavioralStructured 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
DeviceParticipants 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
BehavioralStandardized 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.
Apnea-Hypopnea Index (AHI)
AHI at week 12, adjusted for baseline AHI, assessed by overnight sleep recording and scored according to the prespecified study scoring criteria, expressed in events/hour.
Change in Mandibular Excursion
Change in mandibular excursion (mm) between baseline and Week 12, defined as the mean of 3 George Gauge measurements, expressed in millimeters (mm)
Change in Apnea-Hypopnea Index (AHI) Over Follow-up
Change in AHI from baseline to follow-up visits, assessed by sleep recording and scored according to the prespecified study scoring criteria; expressed in events/hour.
Change in Oxygen Desaturation Index (ODI)
Change in oxygen desaturation index from baseline, assessed by overnight sleep recording; expressed in events/hour.
Change in Oxygen Saturation Nadir (SpO2 nadir)
Change in lowest overnight oxygen saturation from baseline, assessed by overnight sleep recording; expressed in percent (%).
Participants With at Least 1 Treatment-Emergent Adverse Event
Number of participants with at least 1 adverse event (e.g., worsening of daytime sleepiness or sleep quality, temporomandibular pain or functional limitation, non-tolerance to CPAP or any others adverse events) occurring after initiation of study treatment; expressed as number of participants.
Participants Who Discontinued Assigned Treatment Due to Adverse Events or Intolerance
Number of participants who discontinued CPAP or orofacial myofunctional therapy because of adverse events or treatment intolerance; expressed as number of participants.
Participants Withdrawn From the Study Due to Adverse Events
Number of participants withdrawn from the study because of adverse events (e.g., worsening of daytime sleepiness or sleep quality, temporomandibular pain or functional limitation or any others adverse events) ; expressed as number of participants.
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