ClinicalTrials.gg
Enrolling by invitationNCT07301125Updated Oct 28, 2026

Myofunctional Therapy for Obstructive Sleep Apnea

An interventional study of Myofunctional Therapy in Obstructive Sleep Apnea, sponsored by University of Minnesota. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by University of Minnesota · Not applicable, Interventional, and Basic science

Updated Oct 27, 2026Start date movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Obstructive Sleep Apnea

Keywords

  • Obstructive Sleep Apnea
  • Myofunctional Therapy
  • High-Resolution Manometry
03

In context

Sleep Apnea, Obstructive

2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.

This study's planned enrollment of 30 is below the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.

Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 18-65
  • New diagnosis of OSA (AHI ≥ 5) or failure of OSA treatment
  • Willingness to forego first-line OSA treatment or stop current OSA treatment for 3 months

Exclusion criteria

Exclusion Criteria:

  • 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)
  • Very severe insomnia (ISI > 22)
  • (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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Myofunctional Therapy

    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.

    Procedure: Myofunctional Therapy

Interventions

  • ProcedureMyofunctional Therapy

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 90

  2. 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

    Time frame: Day 90

07

Study locations

1 site
08

Updates

3 registry updates since Sep 25, 2026
Start date
Oct 15, 2026→Oct 27, 2026
moved 2 times, Oct 20, 2026 – Oct 27, 2026
Show all 3 updates
  1. Oct 28, 2026
    Minor edits only
    + 1 other change: date precision
  2. Oct 27, 2026
    Start date Oct 23, 2026→Oct 27, 2026
  3. Oct 20, 2026
    Start date Oct 15, 2026→Oct 23, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07301125
Responsible party
Sponsor
First posted
Dec 24, 2025
Start date
Oct 27, 2026
Primary completion
Sep 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Oct 28, 2026

Study contacts

Jesse Hoffmeister, PhD, CCC-SLP
principal investigator · University of Minnesota

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion