Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at San Diego, California
Dates
study started
estimated completion
Principal Investigator
by Carl J Stepnowsky, Jr., PhD

Description

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.

Official Title

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

Details

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.

Keywords

Obstructive Sleep Apnea Sleep Apnea Myofunctional Therapy Chronic Disease Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive OMT Exercises Nasal Breathing Exercises Use of Nasal Lavage Inactive Myofunctional Therapy

Eligibility

You can join if…

Open to people ages 18-70

  • 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

You CAN'T join if...

  • 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

Location

  • VA San Diego Healthcare System, San Diego, CA
    San Diego California 92161 United States

Lead Scientist at UCSD

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
VA Office of Research and Development
ID
NCT04608552
Study Type
Interventional
Last Updated