Myofunctional Therapy for Obstructive Sleep Apnea
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Myofunctional Therapy.
- Who it may be relevant to
- Registry conditions: Obstructive Sleep Apnea. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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.
Primary outcome measures
- MFT treatment fidelity [Time frame: Day 90]
- Pressure generation in posterior upper airway musculature [Time frame: Day 90]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Minnesota — Minneapolis
Identifiers
NCT: NCT07301125 · ENT-2025-33821