Obstructive Sleep Apnea (OSA)NCT07292922
Digital-supported Orofacial Myofunctional Therapy in OSA
A study testing Digital-supported Orofacial Myofunctional Therapy in people with Obstructive Sleep Apnea (OSA), run by Hong Kong Metropolitan University at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- Digital-supported Orofacial Myofunctional Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 5 Jan 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hopsital
Hong Kong, Hong Kong
Agnes Lai, PhD, 91634839, ayklai@hkmu.edu.hk
George OC Cheung, MPhil, 39702917, occheung@hkmu.edu.hk
About this study
Official title: 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.
Read the 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)
- Being tested
- Digital-supported Orofacial Myofunctional Therapy
- Keywords
- Orofacial Myofunctional Therapy
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital-supported Orofacial Myofunctional TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Digital-supported Orofacial Myofunctional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Programme satisfaction
measured by outcome-based questions with a 5-point Likert scale (ranging from 1 to 5 points). Higher scores indicate higher satisfaction.
Measured: month 3
Change in oxygen saturation
Measured by sleep test
Measured: Baseline and month 3
Secondary outcomes (5)
Change in respiratory Indices
Measured by sleep test
Measured: Baseline, month 3
Change in snoring
Measured by sleep test
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline, month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start5 Jan 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Responsible party
- Principal investigator, Dr Agnes LAI Yuen Kwan, Hong Kong Metropolitan University
- Investigators
- Agnes YK Lai, PhD, Principal investigator, Hong Kong Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292922
- Sponsor's protocol ID
- UW 25-461
- Status last verified
- Mar 2026
- First submitted
- 6 Dec 2025
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It has not been mentioned during the IRB application.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital-supported Orofacial Myofunctional Therapy in Subjects With Obstructive Sleep Apnoea: A Pilot Randomised Control Trial
- ClinicalTrials.gov ID
- NCT07292922
- Acronym / sponsor ID
- UW 25-461
- Conditions
- Obstructive Sleep Apnea (OSA)
- Keywords
- Orofacial Myofunctional Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hong Kong Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waitlist Control Group | No intervention | –The waitlist control group will not receive any intervention within the study period |
| d-MFT Intervention Group | Experimental | Behavioral: Digital-supported Orofacial Myofunctional TherapyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital-supported Orofacial Myofunctional TherapyThe 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. | Behavioural | d-MFT Intervention Group |
Primary outcome
Programme satisfaction
Time frame: month 3
measured by outcome-based questions with a 5-point Likert scale (ranging from 1 to 5 points). Higher scores indicate higher satisfaction.
Change in oxygen saturation
Time frame: Baseline and month 3
Measured by sleep test
5 secondary outcomes
Change in respiratory Indices
Time frame: Baseline, month 3
Change in snoring
Time frame: Baseline, month 3
Change in sleep quality
Time frame: Baseline, month 3
Change in daily function
Time frame: Baseline, month 3
Change in oropharyngeal muscle function
Time frame: Baseline, month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No. It has not been mentioned during the IRB application.
Related trials for Obstructive Sleep Apnea (OSA)
RecruitingObservational study
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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Agnes YK Lai, PhD principal investigator
Hong Kong Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital-supported Orofacial Myofunctional Therapy in people with Obstructive Sleep Apnea (OSA), run by Hong Kong Metropolitan University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Agnes YK Lai, PhD ((852)3970-2917, ayklai@hkmu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Programme satisfaction (time frame: month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.