Digital-supported Orofacial Myofunctional Therapy in Subjects With Obstructive Sleep Apnoea: A Pilot Randomized Control Trial
NCT ID: NCT07292922
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-12-31
2027-04-30
Brief Summary
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We expect that participants receiving 3-month d-MFT (n=30) will 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 exploring participants' experiences, satisfaction, and perceived barriers to adherence.
Detailed Description
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The primary objectives of this research are twofold: 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. We hypothesize that participants who receive the d-MFT intervention will 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, Pittsburgh Sleep Quality 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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Waitlist control group
The control (waitlist) group will not receive any intervention within the study period
No interventions assigned to this group
The Intervention group
The 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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Queen Mary Hospital, Hong Kong
OTHER
Hong Kong Metropolitan University
OTHER
Responsible Party
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Dr Agnes LAI Yuen Kwan
Associate Professor
Principal Investigators
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Agnes YK Lai, PhD
Role: PRINCIPAL_INVESTIGATOR
Hong Kong Metropolitan University
Central Contacts
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Other Identifiers
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UW 25-461
Identifier Type: -
Identifier Source: org_study_id