Obstructive Sleep ApneaMFT-OSANCT07231224
A Study of Myofunctional Therapy After Sleep Apnea Surgery
A study testing myofunctional therapy in people with Obstructive Sleep Apnea, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
Obstructive sleep apnea (OSA) is a common disorder characterized by recurrent upper airway collapse. While surgery is a common treatment, its success rates are variable. Myofunctional therapy (MFT), a program of targeted oropharyngeal exercises, has emerged as a promising adjunctive treatment to improve surgical… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- myofunctional therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2020to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20-65 years
- Moderate-to-severe Obstructive Sleep Apnea (AHI ≥ 15 events/hour) confirmed by PSG
- Friedman palate position grade I-II and tonsil size grade III-IV
- Patients who refuse or are unable to tolerate CPAP
Who cannot join
- - Central or mixed sleep apnea
- BMI > 27 kg/m²
- Severe cardiopulmonary disease or psychiatric illness
- Pregnancy or cancer
- Significant weight gain during the follow-up period
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taipei Medical University - Shuang Ho Hospital
New Taipei, Taiwan, 235
About this study
Official title: Postoperative Myofunctional Therapy Enhances Surgical Outcomes in Patients With Obstructive Sleep Apnea: A Prospective Comparative Stud
Obstructive sleep apnea (OSA) is a common disorder characterized by recurrent upper airway collapse. While surgery is a common treatment, its success rates are variable. Myofunctional therapy (MFT), a program of targeted oropharyngeal exercises, has emerged as a promising adjunctive treatment to improve surgical outcomes.
This study prospectively compared outcomes in adult patients with moderate-to-severe OSA who received postoperative MFT (OP+MFT) versus those who underwent surgery alone (OP). Following surgery, patients were allocated to either the OP+MFT group, which began a 12-week MFT program, or the OP-only group. Polysomnography (PSG) was performed at baseline and at 3 and 12 months post-surgery.
The study found that the OP+MFT group showed significantly greater improvements in key sleep parameters, including the Apnea-Hypopnea Index (AHI) and lowest oxygen saturation, compared to the OP group. These benefits were most pronounced at the 3-month follow-up, supporting the conclusion that postoperative MFT is a safe and effective adjunct to surgery for OSA.
Read the detailed description
Obstructive Sleep Apnea (OSA) is a prevalent condition associated with significant morbidity, including hypertension and cardiovascular disease. The first-line treatment, Continuous Positive Airway Pressure (CPAP), is limited by poor long-term patient adherence, with compliance rates often below 20%. For patients who are intolerant to CPAP, surgical options are available, but their long-term success rates are modest, averaging around 30%.
This study is based on the rationale that surgery primarily addresses static anatomical obstructions, while a key functional deficit-poor neuromuscular tone of the upper airway dilator muscles-remains uncorrected by surgery alone. Myofunctional therapy (MFT) is a structured exercise program designed to strengthen oropharyngeal muscles (e.g., tongue, soft palate), improve neuromuscular control, and enhance airway stability during sleep.
This study was designed to evaluate the synergistic effect of combining surgery with postoperative MFT. The hypothesis is that a dual approach, where surgery provides anatomical relief and MFT enhances dynamic airway stability, will lead to superior treatment outcomes compared to surgery alone.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- myofunctional therapy
- Keywords
- Obstructive sleep apnea, Myofunctional therapy (MFT), Upper airway surgery, Oropharyngeal exercises, Postoperative outcomes, Polysomnography (PSG), Apnea-Hypopnea Index (AHI)
- 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.
myofunctional therapyProcedure or surgery
A 12-week structured program of oropharyngeal exercises that commenced three weeks after surgery. The program consisted of initial face-to-face instruction, twice-daily home practice (15 minutes each) guided by videos, and biweekly supervision. Exercises included tongue elevation and protrusion drills, soft palate elevation, and pharyngeal wall contractions to enhance neuromuscular control of the upper airway.
| Study group | Role | What they receive |
|---|---|---|
| OP+MFT Group | Experimental | Participants in this group underwent surgery and began a structured 12-week postoperative myofunctional therapy (MFT) program starting at the third postoperative week. Receives: Procedure: myofunctional therapy |
| OP-only Group | No intervention | Participants in this group underwent the same surgical procedure but received only routine postoperative follow-up without any additional MFT training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Apnea-Hypopnea Index
Change in AHI from baseline, measured by polysomnography in events per hour. Treatment success is defined as a reduction of ≥50% from baseline AHI and a final AHI of <20 events/hour.
Measured: Baseline, 3 months post-surgery, and 12 months post-surgery
Secondary outcomes (2)
Change in Lowest Oxygen Saturation (LSaO₂)
Change in the lowest oxygen saturation (LSaO₂) during sleep, measured by polysomnography as a percentage
Measured: Baseline, 3 months post-surgery, and 12 months post-surgery
Change in Snore Index
Change in the snore index, measured by polysomnography as the percentage of total sleep time with snoring events
Measured: Baseline, 3 months post-surgery, and 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start1 Jan 2020
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Enrolled patients were divided into two parallel groups based on personal willingness after discussion: Group A (OP+MFT) or Group B (OP-only)
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University, National Yang Ming Chiao Tung University Hospital, National Tsing Hua University,Taiwan
- Responsible party
- Sponsor
- Investigators
- CHENGJUNG WU, MD, Principal investigator, Shuang Ho Hospital, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231224
- Sponsor's protocol ID
- TMUJIRB No.201912067
- Other IDs
- W114YSR-03, TMU113-AE1-B04
- Acronym
- MFT-OSA
- Status last verified
- Oct 2025
- First submitted
- 13 Nov 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data presented in this study are available on reasonable request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Myofunctional Therapy Enhances Surgical Outcomes in Patients With Obstructive Sleep Apnea: A Prospective Comparative Stud
- ClinicalTrials.gov ID
- NCT07231224
- Acronym / sponsor ID
- MFT-OSA / TMUJIRB No.201912067
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea, Myofunctional therapy (MFT), Upper airway surgery, Oropharyngeal exercises, Postoperative outcomes, Polysomnography (PSG), Apnea-Hypopnea Index (AHI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Collaborators
- Taipei Medical University, National Yang Ming Chiao Tung University Hospital, National Tsing Hua University,Taiwan
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 17 Nov 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.
Obstructive sleep apnea (OSA) is a common disorder characterized by recurrent upper airway collapse. While surgery is a common treatment, its success rates are variable. Myofunctional therapy (MFT), a program of targeted oropharyngeal exercises, has emerged as a promising adjunctive treatment to improve surgical outcomes.
This study prospectively compared outcomes in adult patients with moderate-to-severe OSA who received postoperative MFT (OP+MFT) versus those who underwent surgery alone (OP). Following surgery, patients were allocated to either the OP+MFT group, which began a 12-week MFT program, or the OP-only group. Polysomnography (PSG) was performed at baseline and at 3 and 12 months post-surgery.
The study found that the OP+MFT group showed significantly greater improvements in key sleep parameters, including the Apnea-Hypopnea Index (AHI) and lowest oxygen saturation, compared to the OP group. These benefits were most pronounced at the 3-month follow-up, supporting the conclusion that postoperative MFT is a safe and effective adjunct to surgery for OSA.
Detailed description
Obstructive Sleep Apnea (OSA) is a prevalent condition associated with significant morbidity, including hypertension and cardiovascular disease. The first-line treatment, Continuous Positive Airway Pressure (CPAP), is limited by poor long-term patient adherence, with compliance rates often below 20%. For patients who are intolerant to CPAP, surgical options are available, but their long-term success rates are modest, averaging around 30%.
This study is based on the rationale that surgery primarily addresses static anatomical obstructions, while a key functional deficit-poor neuromuscular tone of the upper airway dilator muscles-remains uncorrected by surgery alone. Myofunctional therapy (MFT) is a structured exercise program designed to strengthen oropharyngeal muscles (e.g., tongue, soft palate), improve neuromuscular control, and enhance airway stability during sleep.
This study was designed to evaluate the synergistic effect of combining surgery with postoperative MFT. The hypothesis is that a dual approach, where surgery provides anatomical relief and MFT enhances dynamic airway stability, will lead to superior treatment outcomes compared to surgery alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Enrolled patients were divided into two parallel groups based on personal willingness after discussion: Group A (OP+MFT) or Group B (OP-only)
| Arm | Type | Receives |
|---|---|---|
| OP+MFT Group | Experimental | Procedure: myofunctional therapyParticipants in this group underwent surgery and began a structured 12-week postoperative myofunctional therapy (MFT) program starting at the third postoperative week. |
| OP-only Group | No intervention | –Participants in this group underwent the same surgical procedure but received only routine postoperative follow-up without any additional MFT training. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 20-65 years
- Moderate-to-severe Obstructive Sleep Apnea (AHI ≥ 15 events/hour) confirmed by PSG
- Friedman palate position grade I-II and tonsil size grade III-IV
- Patients who refuse or are unable to tolerate CPAP
Key exclusion criteria (5 listed)
- - Central or mixed sleep apnea
- BMI > 27 kg/m²
- Severe cardiopulmonary disease or psychiatric illness
- Pregnancy or cancer
- Significant weight gain during the follow-up period
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 |
|---|---|---|
| myofunctional therapyA 12-week structured program of oropharyngeal exercises that commenced three weeks after surgery. The program consisted of initial face-to-face instruction, twice-daily home practice (15 minutes each) guided by videos, and biweekly supervision. Exercises included tongue elevation and protrusion drills, soft palate elevation, and pharyngeal wall contractions to enhance neuromuscular control of the upper airway. | Procedure or surgery | OP+MFT Group |
Primary outcome
Change in Apnea-Hypopnea Index
Time frame: Baseline, 3 months post-surgery, and 12 months post-surgery
Change in AHI from baseline, measured by polysomnography in events per hour. Treatment success is defined as a reduction of ≥50% from baseline AHI and a final AHI of <20 events/hour.
2 secondary outcomes
Change in Lowest Oxygen Saturation (LSaO₂)
Time frame: Baseline, 3 months post-surgery, and 12 months post-surgery
Change in Snore Index
Time frame: Baseline, 3 months post-surgery, and 12 months post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: Yes. The data presented in this study are available on reasonable request from the corresponding author
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
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RecruitingPhase 3
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. This study is not recruiting at the moment.
CHENGJUNG WU, MD principal investigator
Shuang Ho Hospital, Taipei Medical 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 myofunctional therapy in people with Obstructive Sleep Apnea, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
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 5 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: finished, as of the sponsor's last update on 17 Nov 2025. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Apnea-Hypopnea Index (time frame: Baseline, 3 months post-surgery, and 12 months post-surgery). 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 17 Nov 2025.