Orofacial Myofunctional Therapy and Positive Airway Pressure-CPAP Trial for Mild-to-Moderate Obst… (NCT07539870) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Orofacial Myofunctional Therapy and Positive Airway Pressure-CPAP Trial for Mild-to-Moderate Obstructive Sleep Apnea
168 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* Ability to perform oropharyngeal exercises.
* Written informed consent.
Exclusion Criteria:
* 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.
* Current use of medications likely to affect sleep architecture, respiratory drive, or PAP tolerance, including chronic opioid therapy and other sedative medications judged incompatible with study participation.
* Unstable or severe cardiovascular disease requiring priority standard management, including poorly controlled arrhythmia, nocturnal angina, decompensated heart failure, treatment-resistant hypertension, or recent acute coronary syndrome
* Uncontrolled diabetes mellitus requiring treatment intensification, for example - HbA1c greater …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.