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Clinical Trials/NCT04608552
NCT04608552CompletedNot Applicable

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

VA Office of Research and Development2 sites in 1 country209 target enrollmentStarted: August 2, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
209
Locations
2
Primary Endpoint
Change in Apnea Hypopnea Index (AHI; measure of sleep apnea disease severity)

Study Overview

Brief Summary

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.

Detailed Description

The purpose of this study is to examine the effect of Orofacial Myofunctional Therapy in Veterans with mild-to-moderate sleep apnea. The main question to be answered is whether OMT improves measures of OSA severity, patient functional status, and OSA symptoms when compared to sham OMT.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Mild-to-moderate OSA
  • •Entry criteria are as inclusive as possible and operationalized as follows: age>18 years old
  • •Confirmed diagnosis of OSA
  • •Having chronic symptoms per screening symptom checklist
  • •Fluency in English
  • •Must be getting care the VA San Diego Healthcare System

Exclusion Criteria

  • •Cognitive impairment sufficient to cause inability to complete the protocol (per medical chart review)
  • •Low health literacy
  • •Residence in a geographical area outside of San Diego County
  • •Fatal comorbidity (life expectancy <6 months as indicated by treating physician)
  • •Significant documented substance/chemical abuse

Arms & Interventions

Active Myofunctional Therapy

Active Comparator

Active Myofunctional Therapy is comprised of five 30-minute weekly sessions for 4 weeks.

Intervention: OMT Exercises (Behavioral)

Inactive Myofunctional Therapy

Sham Comparator

Sham MT will be comprised of recommendations for five 30-minute nasal breathing exercises each week, use of nasal lavage with application of 10ml of saline in each nostril two times per day.

Intervention: Nasal Breathing Exercises (Behavioral)

Inactive Myofunctional Therapy

Sham Comparator

Sham MT will be comprised of recommendations for five 30-minute nasal breathing exercises each week, use of nasal lavage with application of 10ml of saline in each nostril two times per day.

Intervention: Use of Nasal Lavage (Other)

Outcomes

Primary Outcomes

Change in Apnea Hypopnea Index (AHI; measure of sleep apnea disease severity)

Time Frame: 3 months and 6 months

Compare the change in AHI between OMT and inactive OMT groups over the follow-up time points. Higher AHI scores indicate increase sleep apnea disease severity.

Secondary Outcomes

  • Change in Epworth Sleepiness Score (ESS; measure of sleepiness)(3 months and 6 months)
  • Change in Functional Outcomes of Sleep Questionnaire (FOSQ; measure of daytime functioning)(3 months and 6 months)
  • Change in Pittsburgh Sleep Quality Index (PSQI; measure of sleep quality)(3 months and 6 months)

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (2)

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