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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Procedure: Myofunctional Therapy

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	Day 90

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Jesse Hoffmeister, PhD, CCC-SLP, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Estimated): June 10, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Obstructive Sleep Apnea; Myofunctional Therapy; High-Resolution Manometry
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Therapeutics; Physical Therapy Modalities; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Rehabilitation of Speech and Language Disorders; Dentistry; Myofunctional Therapy
• Other Study ID Numbers: ENT-2025-33821

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes