Digital-supported Orofacial Myofunctional Therapy in OSA
ConditionObstructive Sleep Apnea (OSA)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHong Kong Metropolitan University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Presence of obstructive nasal disease or significant nasal obstruction
Unstable mental health issues
History of stroke
Unstable chronic respiratory, cardiac, neurological conditions
Trial design
Design model
Parallel
Treatments tested in this trial
Digital-supported Orofacial Myofunctional Therapy
BehavioralThe 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Waitlist Control GroupNo intervention 0 interventions
Group B: d-MFT Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Programme satisfaction
measured by outcome-based questions with a 5-point Likert scale (ranging from 1 to 5 points). Higher scores indicate higher satisfaction.
Time frame
month 32
Change in oxygen saturation
Measured by sleep test
Time frame
Baseline and month 3Secondary outcomes
1
Change in respiratory Indices
Measured by sleep test
Time frame
Baseline, month 32
Change in snoring
Measured by sleep test
Time frame
Baseline, month 33
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).
Time frame
Baseline, month 34
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.
Time frame
Baseline, month 3Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hong Kong Metropolitan University
Lead sponsor
Queen Mary Hospital, Hong Kong
Collaborator
Source ClinicalTrials.gov