Myofunctional Therapy for Obstructive Sleep Apnea

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myofunctional Therapy

Procedure

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 outcomes

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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Dec 24, 2025
Registry last updated: Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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