Actively Recruiting
Digital-supported Orofacial Myofunctional Therapy in Subjects With Obstructive Sleep Apnoea: A Pilot Randomised Control Trial
Led by Hong Kong Metropolitan University · Updated on 2026-03-13
60
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
H
Hong Kong Metropolitan University
Lead Sponsor
Q
Queen Mary Hospital, Hong Kong
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating Digital-supported Orofacial Myofunctional Therapy (d-MFT) for adults with mild to moderate obstructive sleep apnea (OSA). This pilot randomized controlled trial aims to assess the feasibility, acceptability, and early effectiveness of d-MFT, which combines facial recognition technology with proven orofacial exercises to strengthen throat muscles, improve airway function, and reduce OSA severity and symptoms. The study also explores participant satisfaction and barriers to using the therapy. Participants are randomly assigned to either a d-MFT intervention group or a waitlist control group. The intervention includes five 30-minute d-MFT sessions, two follow-up phone calls, and daily home exercises guided by a mobile app that offers real-time feedback and tracks adherence over three months. The control group receives no intervention during this period but continues usual care. After three months, outcome assessments are conducted for both groups. During the study, participants undergo polysomnography and complete questionnaires measuring sleepiness, sleep quality, and daily function at the start and end of the three months. Researchers also measure tongue pressure to assess muscle function. Adherence is monitored electronically through the app. Feasibility and acceptability are further evaluated via interviews to understand participants’ experiences and satisfaction. The total study duration for participants is three months, with data collected at baseline and after completing the intervention.
CONDITIONS
Brief Title
Digital-supported Orofacial Myofunctional Therapy in OSA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and above
- Diagnosed with mild to moderate obstructive sleep apnoea (Apnoea-Hypopnea Index of 5-30 events per hour)
- Indications for Continuous Positive Airway Pressure or oral appliance treatment but unable to tolerate or declined these treatments
- Body Mass Index less than 30 kg/m2
You will not qualify if you...
- Presence of obstructive nasal disease or significant nasal obstruction
- Unstable mental health issues
- History of stroke
- Unstable chronic respiratory, cardiac, or neurological conditions
- Inability to provide informed consent
- Prior oral, pharyngeal, or maxillofacial surgical therapy for sleep apnoea
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants in the intervention group complete a 3-month digital-supported orofacial myofunctional therapy program consisting of five 30-minute sessions, two follow-up phone calls, and daily home exercises using a dedicated mobile app with real-time feedback.
5 sessions and 2 phone calls over 3 months
Duration - 3 months
Participants in the control group continue their usual care during this 3-month period without receiving the intervention.
No intervention visits
Duration - 1 day
After 3 months, participants undergo outcome assessments including sleep studies, questionnaires, and muscle function tests to evaluate therapy effects and adherence.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Queen Mary Hopsital
Hong Kong, Hong Kong, Hong Kong
Actively Recruiting
Research Team
A
Agnes YK Lai, PhD
G
George OC Cheung, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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