RecruitingNot Applicable

Myofunctional Therapy for Obstructive Sleep Apnea

United States30 participantsStarted 2026-06-30

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 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) * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is measuring 'treatment fidelity' and pressure in the throat muscles rather than directly measuring whether my sleep apnea symptoms improve — does that mean it's too early in the research process to know if myofunctional therapy would actually help me?
2Since this trial has no listed phase and seems focused on how well the therapy is delivered and how it affects throat muscle pressure, what would my doctor expect me to get out of participating compared to just starting standard treatment like a CPAP?
3Myofunctional therapy involves doing mouth and throat exercises regularly — how demanding is that kind of commitment day-to-day, and is that realistic given my current situation?
4Are there any risks my doctor sees in participating in a study like this, even though the therapy itself seems non-invasive, particularly if my sleep apnea is moderate or severe and I'd be delaying other proven treatments?
5Would my doctor recommend I try an established treatment for my obstructive sleep apnea first, and then revisit whether a study like this makes sense, or does participating now make more sense given where I am in my diagnosis?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

MFT treatment fidelity

Timeframe: Day 90

Pressure generation in posterior upper airway musculature

Timeframe: Day 90

Trial details

NCT IDNCT07301125

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-30

Contact for this trial

Marissa Anderson, MPH

mnvoicelab@umn.edu

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials