Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • 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.

Recruiting Locations

University of Minnesota
Minneapolis 5037649, Minnesota 5037779 55455
Contact:
Marissa Anderson, MPH
mnvoicelab@umn.edu

More Details

Status
Recruiting
Sponsor
University of Minnesota

Study Contact

Marissa Anderson, MPH
mnvoicelab@umn.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.