NCT07301125 · University of Minnesota
Myofunctional Therapy for Obstructive Sleep Apnea
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
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.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Minneapolis, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 16, 2026 · Source of record for eligibility and locations