Myofunctional Therapy for Obstructive Sleep Apnea

University of Minnesota (UMN)

Status: Enrolling

Conditions: Obstructive Sleep Apnea

Treatments: Procedure: Myofunctional Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07301125

ENT-2025-33821

Details and patient eligibility

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. 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Myofunctional Therapy

Experimental group

Description:

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.

Treatment:

Procedure: Myofunctional Therapy