Digital-supported Orofacial Myofunctional Therapy in OSA

Digital-supported Orofacial Myofunctional Therapy in Subjects With Obstructive Sleep Apnoea: A Pilot Randomised Control Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea (OSA)
• Intervention / Treatment: Behavioral: Digital-supported Orofacial Myofunctional Therapy

Detailed Description

This pilot study investigates the feasibility, acceptability, and preliminary effectiveness of Digital-supported Orofacial Myofunctional Therapy (d-MFT), an innovative approach that integrates facial recognition technology with evidence-based orofacial exercises tailored for individuals with mild to moderate obstructive sleep apnoea (OSA). Grounded on Self-Determination Theory, the d-MFT program aims to strengthen oropharyngeal muscles, enhance airway function, and alleviate OSA severity and snoring (if any). The intervention consists of five 30-minute sessions and two follow-up phone calls conducted over three months, all delivered through a dedicated mobile application that provides real-time feedback and tracks adherence.

The primary objectives of this research are twofolds: first, to evaluate whether d-MFT effectively reduces OSA severity and associated symptoms, and second, to identify barriers and facilitators to its implementation in real-world settings. Participants who receive the d-MFT intervention are expected to show greater improvements in OSA severity, sleep-related symptoms, and overall quality of life compared to those in the control group.

This randomized controlled trial will recruit 60 participants, divided into two groups of 30 each, all diagnosed with mild to moderate OSA (apnoea-hypopnea index [AHI] of 5-30 events per hour). Individuals with severe comorbidities or a history of OSA-related surgery will be excluded. The intervention group will engage with the d-MFT app daily for three months, while the control group will continue their usual care before transitioning to the intervention after the assessment.

Outcomes will be measured at baseline and after three months. Objective assessments will include polysomnography to evaluate the apnoea-hypopnea index, oxygen desaturation index, and snoring severity. Subjective evaluations will be conducted using standardized questionnaires such as the Epworth Sleepiness Scale, Insomian Severity Index, and Functional Outcomes of Sleep Questionnaire, providing insights into daytime sleepiness, sleep quality, and quality of life. Additionally, oropharyngeal muscle function will be assessed through tongue pressure measurements. Adherence to the d-MFT program will be monitored using electronic logs within the app.

Feasibility and acceptability will be assessed through semi-structured interviews that explore participants' experiences, levels of satisfaction, and perceived barriers to adherence. For quantitative data analysis, linear mixed-effects models will be utilized to account for repeated measurements and potential confounders, while qualitative data will be analyzed through thematic content analysis.

This study represents a promising non-invasive alternative that addresses existing treatment challenges by employing technology-enhanced therapy aimed at improving both adherence and clinical outcomes. Ultimately, the findings from this pilot study have the potential to significantly advance the management of obstructive sleep apnoea through broader implementation of d-MFT.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Agnes YK Lai, PhD; Phone Number: (852)3970-2917; Email: ayklai@hkmu.edu.hk
• Study Contact Backup: Name: George OC Cheung, MSc; Phone Number: (852)3970-2917; Email: occheung@hkmu.edu.hk

Study Locations

• Hong Kong
  • Hong Kong
    • Hong Kong, Hong Kong, Hong Kong
      • Recruiting
      • Queen Mary Hopsital
      • Contact: Agnes Lai, PhD; Phone Number: 91634839; Email: ayklai@hkmu.edu.hk
      • Contact: George OC Cheung, MPhil; Phone Number: 39702917; Email: occheung@hkmu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waitlist Control Group; The waitlist control group will not receive any intervention within the study period
Experimental: d-MFT Intervention Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in oxygen saturation	Measured by sleep test	Baseline and month 3
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in respiratory Indices	Measured by sleep test	Baseline, month 3
Change in snoring	Measured by sleep test	Baseline, month 3
Change in sleep quality	Measured by Insomnia Severity Scale, a 7-item questionnaire that assesses the severity of insomnia symptoms. Scores ranged from 0 to 28, with cutoffs for no clinically significant insomnia (0-7), subthreshold insomnia (8-14), moderate clinical insomnia (15-21), and severe clinical insomnia (22-28).	Baseline, month 3
Change in daily function	Measured by Functional Outcomes of Sleep Questionnaire (FOSQ-10). A self-reported questionnaire designed to access the impact of excessive sleepiness on multiple daily activities. It consists of 10 items that evaluate various dimensions of sleep-related functional outcomes. Each item is rated on a 4 to 5-point Likert scale, with higher scores indicating less difficulty and better functional status. The total score is calculated by averaging the responses and converting them to a scale ranging from 5 to 20, with lower scores suggesting that sleep disturbances significantly impair daily functioning.	Baseline, month 3
Change in oropharyngeal muscle function	Measured by Tongue Pressure assessment, which is an objective assessment of oropharyngeal muscle function, indicating the strength of the tongue during contraction.	Baseline, month 3

Collaborators and Investigators

• Sponsor: Hong Kong Metropolitan University
• Collaborators: Queen Mary Hospital, Hong Kong
• Investigators: Principal Investigator: Agnes YK Lai, PhD, Hong Kong Metropolitan University

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: December 6, 2025
• First Submitted That Met QC Criteria: December 6, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Orofacial Myofunctional Therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: UW 25-461

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It has not been mentioned during the IRB application.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No