NCT07292922

Digital-supported Orofacial Myofunctional Therapy in OSA

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hong Kong Metropolitan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Obstructive Sleep Apnea (OSA)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-05
• Primary completion: 2027-01-31
• Completion: 2027-04-30
• First posted: 2025-12-18
• Last updated: 2026-03-13

Locations

1 site across 1 country: Hong Kong