NCT07301125

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
16mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 24, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

June 10, 2026

Expected
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

November 25, 2025

Last Update Submit

April 14, 2026

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep ApneaMyofunctional TherapyHigh-Resolution Manometry

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Myofunctional Therapy

EXPERIMENTAL

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

Interventions

Myofunctional TherapyPROCEDURE

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.

Myofunctional Therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Myofunctional Therapy

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language DisordersRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesDentistry

Study Officials

  • Jesse Hoffmeister, PhD, CCC-SLP

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2025

First Posted

December 24, 2025

Study Start (Estimated)

June 10, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations

US(1)