App-guided orofacial muscle training for mild to moderate obstructive sleep apnea.
Digital-supported Orofacial Myofunctional Therapy in Subjects With Obstructive Sleep Apnoea: A Pilot Randomised Control Trial
This trial will test a three-month app-delivered facial-recognition guided orofacial exercise program to see if it reduces sleep apnea severity and symptoms in adults with mild to moderate OSA who cannot tolerate or decline CPAP or oral appliances.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hong Kong Metropolitan University Academic / other |
| Locations | 1 site (Hong Kong, Hong Kong) |
| Trial ID | NCT07292922 on ClinicalTrials.gov |
What this trial studies
This randomized pilot trial will compare a 3-month digital-supported orofacial myofunctional therapy (d-MFT) program to a waitlist control in 60 adults with mild to moderate OSA. The d-MFT intervention uses a mobile app with facial-recognition feedback to deliver five 30-minute exercise sessions plus two follow-up phone calls, and it tracks adherence and performance in real time. Primary outcomes include change in OSA severity (AHI), sleep-related symptoms, and quality of life, while feasibility and acceptability are measured with questionnaires and semi-structured interviews. Key exclusions include prior OSA-related surgery, significant nasal obstruction, unstable chronic medical or psychiatric conditions, and BMI ≥30 to focus on a population most likely to benefit.
Who should consider this trial
Good fit: Adults aged 18 and over with mild to moderate OSA (AHI 5–30) who are indicated for CPAP or oral appliance therapy but cannot tolerate or decline those treatments and have BMI under 30 kg/m2.
Not a fit: Patients with severe OSA, significant nasal obstruction, unstable chronic medical or psychiatric conditions, prior OSA-related surgery, or BMI ≥30 are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, d-MFT could offer a non-invasive, home-based option to reduce OSA severity and improve sleep-related symptoms for patients who cannot use CPAP or oral appliances.
How similar studies have performed: Prior trials of orofacial myofunctional therapy have shown modest improvements in AHI and symptoms for mild to moderate OSA, but the use of facial-recognition guided, app-delivered programs is relatively novel and not yet widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years and above * Diagnosed with mild to moderate Obstructive Sleep Apnoea, defined as: Apnoea-Hypopnea Index of 5-30 events per hour * Indications for Continuous Positive Airway Pressure or oral appliance treatment, but unable to tolerate or decline these treatments * Body Mass Index less than 30 kg/m2 Exclusion Criteria: * Presence of obstructive nasal disease or significant nasal obstruction * Unstable mental health issues * History of stroke * Unstable chronic respiratory, cardiac, neurological conditions * Inability to provide informed consent * Prior oral, pharyngeal, or maxillofacial surgical therapy for sleep apnoea
Where this trial is running
Hong Kong, Hong Kong
- Queen Mary Hopsital — Hong Kong, Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Agnes YK Lai, PhD — Hong Kong Metropolitan University
- Study coordinator: Agnes YK Lai, PhD
- Email: ayklai@hkmu.edu.hk
- Phone: (852)3970-2917
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.