Digital-supported Orofacial Myofunctional Therapy in OSA

NCT07292922 | Recruiting

• 1 other identifier: UW 25-461
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study explores the feasibility, acceptability, and preliminary effectiveness of Digital-supported Orofacial Myofunctional Therapy (d-MFT), an innovative program combining facial recognition technology with evidence-based orofacial exercises for individuals with mild to moderate obstructive sleep apnoea (OSA). The d-MFT program aims to strengthen oropharyngeal muscles, improve airway function, and reduce OSA severity. Participants receiving 3-month d-MFT (n=30) are expected to demonstrate greater improvements in OSA severity, sleep-related symptoms, and quality of life compared to those in the waitlist control group (n=30). Feasibility and acceptability will be evaluated through outcome-based questionnaires and semi-structured interviews to explore participants' experiences, satisfaction, and perceived barriers to adherence.

Conditions

Obstructive Sleep Apnea (OSA)

Keywords

Orofacial Myofunctional Therapy

Outcome Measures

Primary Outcomes (2)

• Programme satisfaction

  measured by outcome-based questions with a 5-point Likert scale (ranging from 1 to 5 points). Higher scores indicate higher satisfaction.

  month 3

• Change in oxygen saturation

  Measured by sleep test

  Baseline and month 3

Secondary Outcomes (5)

• Change in respiratory Indices

  Baseline, month 3

• Change in snoring

  Baseline, month 3

• Change in sleep quality

  Baseline, month 3

• Change in daily function

  Baseline, month 3

• Change in oropharyngeal muscle function

  Baseline, month 3

Study Arms (2)

Waitlist Control Group

NO INTERVENTION

The waitlist control group will not receive any intervention within the study period

d-MFT Intervention Group

EXPERIMENTAL

The d-MFT intervention group will participate in a 3-month digital-support Myofunctional Therapy program. This innovative program is designed to ensure proper exercise performance, enhance adherence, and provide real-time feedback to patients.

Behavioral: Digital-supported Orofacial Myofunctional Therapy

Interventions

Digital-supported Orofacial Myofunctional Therapy BEHAVIORAL

The intervention include: (1) Five 30-minute d-MFT sessions; (2) two follow-up phone calls; and (3) facial and tongue exercise app for home practice.

d-MFT Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hong Kong Metropolitan University: lead
• Queen Mary Hospital, Hong Kong: collaborator

Study Sites (1)

Queen Mary Hopsital

Hong Kong, Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Agnes YK Lai, PhD

  Hong Kong Metropolitan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnes YK Lai, PhD

CONTACT

(852)3970-2917; ayklai@hkmu.edu.hk

George OC Cheung, MSc

CONTACT

(852)3970-2917; occheung@hkmu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 6, 2025
• First Posted: December 18, 2025
• Study Start: January 5, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)