COMPLETED

Effect of Myofunctional Therapy on OSA

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary medical therapies for patients with Obstructive Sleep Apnea syndrome (OSA) require the use of medical devices on a nightly basis to help control breathing during sleep, which can be difficult for patients with mild-to-moderate disease. Because many patients use these therapies on a limited basis, or stop using them altogether, they continue to be at increased risk of the consequences of untreated OSA. Untreated and undertreated OSA compounds the risk of OSA consequences over time, particularly with increasing age and weight. Orofacial Myofunctional Therapy (OMT) takes a rehabilitative approach to OSA and is comprised of isotonic and isometric exercises that target the oral (e.g., tongue) and oropharyngeal (e.g., soft palate, lateral pharyngeal wall) to help restore normal breathing and airway patency at night while asleep. Should the study have positive findings, OMT could become an important alternative therapy for patients with mild-to-moderate disease because patients could utilize a therapy that improves their nighttime breathing through daytime exercises and without the need for a burdensome medical device.

Official Title

Effect of Myofunctional Therapy on Outcomes in Mild to Moderate Sleep Apnea

Quick Facts

Study Start:2021-08-02
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04608552

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Mild-to-moderate OSA
  2. * Entry criteria are as inclusive as possible and operationalized as follows: age\>18 years old
  3. * Confirmed diagnosis of OSA
  4. * Having chronic symptoms per screening symptom checklist
  5. * Fluency in English
  6. * Must be getting care the VA San Diego Healthcare System
  1. * Cognitive impairment sufficient to cause inability to complete the protocol (per medical chart review)
  2. * Low health literacy
  3. * Residence in a geographical area outside of San Diego County
  4. * Fatal comorbidity (life expectancy \<6 months as indicated by treating physician)
  5. * Significant documented substance/chemical abuse

Contacts and Locations

Principal Investigator

Carl J Stepnowsky, Jr., PhD
PRINCIPAL_INVESTIGATOR
VA San Diego Healthcare System, San Diego, CA

Study Locations (Sites)

VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Carl J Stepnowsky, Jr., PhD, PRINCIPAL_INVESTIGATOR, VA San Diego Healthcare System, San Diego, CA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-02
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2021-08-02
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Sleep Apnea
  • Myofunctional Therapy
  • Chronic Disease

Additional Relevant MeSH Terms

  • Obstructive Sleep Apnea