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Myofunctional Therapy for Obstructive Sleep Apnea

NCT ID: NCT07301125

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2027-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea

Keywords

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Obstructive Sleep Apnea Myofunctional Therapy High-Resolution Manometry

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Myofunctional Therapy

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jesse Hoffmeister, PhD, CCC-SLP

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Central Contacts

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Marissa Anderson, MPH

Role: CONTACT

Email: [email protected]

Facility Contacts

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Marissa Anderson, MPH

Role: primary

Other Identifiers

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ENT-2025-33821

Identifier Type: -

Identifier Source: org_study_id