Obstructive Sleep ApneaNCT07301125
Myofunctional Therapy for Obstructive Sleep Apnea
A study testing Myofunctional Therapy in people with Obstructive Sleep Apnea, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to explore a new way to examine the function of the muscles using a technique called high-resolution manometry. The study will enroll 30 adults with OSA, all of whom will use the myofunctional therapy (MFT) devices for 3 months. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Myofunctional Therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2026to 30 Sep 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65
- New diagnosis of OSA (AHI ≥ 5) or failure of first-line OSA treatment
- Willingness to forego first-line OSA treatment or stop current OSA treatment for 3 months
Who cannot join
- Medical comorbidities that require restricting fluid intake (e.g., dysphagia, renal disease, liver disease, hyponatremia)
- Severe nasal obstruction
- Severe ankyloglossia
- Craniofacial abnormality
- Severe pulmonary disease
- Severe post-traumatic stress disorder (PCL-5 \> 33)
Show all 21Show fewer
- Very severe insomnia (ISI \> 22)
- Body mass index (BMI) ≥30 kg/m2.
- History of TBI
- Known oropharyngeal or esophageal dysphagia
- Pregnancy
- Allergy to topical anesthetic
- Inability to fast for 6 hours
- Recent facial trauma
- Recent nasal, pharyngeal, laryngeal, or esophageal surgery
- Known nasal, pharyngeal or esophageal obstruction
- Current upper respiratory infection
- Insufficient internet/computer access to participate in remote study visit
- Severe excessive daytime sleepiness (risk of motor vehicle accidents)
- Heart failure, recent stroke, heart attack, etc.
- Nasal Obstruction Symptom Evaluation (NOSE) Scale \>15
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The purpose of this study is to explore a new way to examine the function of the muscles using a technique called high-resolution manometry. The study will enroll 30 adults with OSA, all of whom will use the myofunctional therapy (MFT) devices for 3 months. High-resolution manometry will be used to measure the amount of pressure generated by the muscles of the throat when drinking water or breathing air, both with and without the MFT devices, and before and after the MFT intervention. If successful, this method can help us understand why sleep improves after MFT.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Myofunctional Therapy
- Keywords
- Obstructive Sleep Apnea, Myofunctional Therapy, High-Resolution Manometry
- 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
The intervention consists of 90 days of MFT (5-6 days/week) along with completing daily logs.
MFT will include high-intensity swallowing exercises and respiratory muscle strength training.
| Study group | Role | What they receive |
|---|---|---|
| Myofunctional Therapy | Experimental | The intervention consists of 90 days of MFT (5-6 days/week) along with completing daily logs.
MFT will include high-intensity swallowing exercises and respiratory muscle strength training.
Before and after the MFT intervention period, there will be a research visit that includes answering questionnaires about symptoms and health, performing throat HRM, and assessing oral and facial muscles involved in swallowing. Receives: Procedure: Myofunctional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MFT treatment fidelity
Treatment fidelity of two common MFTs (high-intensity swallowing exercises, respiratory muscle strength training) in individuals with OSA. Treatment fidelity will be determined via measuring the percent of sessions completed relative to the targeted number of sessions.
Measured: Day 90
Pressure generation in posterior upper airway musculature
Comparison of pressure generation in posterior upper airway musculature before and after MFT intervention as assessed with HRM
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start23 Oct 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 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 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jesse Hoffmeister, PhD, CCC-SLP, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301125
- Sponsor's protocol ID
- ENT-2025-33821
- Status last verified
- Oct 2026
- First submitted
- 25 Nov 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myofunctional Therapy for Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT07301125
- Acronym / sponsor ID
- ENT-2025-33821
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea, Myofunctional Therapy, High-Resolution Manometry
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 23 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 24 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.
The purpose of this study is to explore a new way to examine the function of the muscles using a technique called high-resolution manometry. The study will enroll 30 adults with OSA, all of whom will use the myofunctional therapy (MFT) devices for 3 months. High-resolution manometry will be used to measure the amount of pressure generated by the muscles of the throat when drinking water or breathing air, both with and without the MFT devices, and before and after the MFT intervention. If successful, this method can help us understand why sleep improves after MFT.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myofunctional Therapy | Experimental | Procedure: Myofunctional TherapyThe intervention consists of 90 days of MFT (5-6 days/week) along with completing daily logs. MFT will include high-intensity swallowing exercises and respiratory muscle strength training. Before and after the MFT intervention period, there will be a research visit that includes answering questionnaires about symptoms and health, performing throat HRM, and assessing oral and facial muscles involved in swallowing. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18-65
- New diagnosis of OSA (AHI ≥ 5) or failure of first-line OSA treatment
- Willingness to forego first-line OSA treatment or stop current OSA treatment for 3 months
Key exclusion criteria (21 listed)
- Medical comorbidities that require restricting fluid intake (e.g., dysphagia, renal disease, liver disease, hyponatremia)
- Severe nasal obstruction
- Severe ankyloglossia
- Craniofacial abnormality
- Severe pulmonary disease
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 TherapyThe intervention consists of 90 days of MFT (5-6 days/week) along with completing daily logs. MFT will include high-intensity swallowing exercises and respiratory muscle strength training. | Procedure or surgery | Myofunctional Therapy |
Primary outcome
MFT treatment fidelity
Time frame: Day 90
Treatment fidelity of two common MFTs (high-intensity swallowing exercises, respiratory muscle strength training) in individuals with OSA. Treatment fidelity will be determined via measuring the percent of sessions completed relative to the targeted number of sessions.
Pressure generation in posterior upper airway musculature
Time frame: Day 90
Comparison of pressure generation in posterior upper airway musculature before and after MFT intervention as assessed with HRM
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 20 Oct 2026.
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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.
Jesse Hoffmeister, PhD, CCC-SLP principal investigator
University of Minnesota
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 University of Minnesota at 1 site in United States.
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 3 inclusion and 21 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: enrolling by invitation, as of the sponsor's last update on 20 Oct 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 United States. 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?
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?
MFT treatment fidelity (time frame: Day 90). 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 20 Oct 2026.