Myofunctional Therapy for Obstructive Sleep Apnea

ConditionObstructive Sleep Apnea

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorUniversity of Minnesota

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Medical comorbidities that require restricting fluid intake (e.g., dysphagia, renal disease, liver disease, hyponatremia)

Severe nasal obstruction

Severe ankyloglossia

Craniofacial abnormality

Trial design

Design model

Single group

Treatments tested in this trial

Myofunctional Therapy
Procedure/Surgery
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.

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Myofunctional TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Time frame

Day 90

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

Source ClinicalTrials.gov

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