Clinical trial NCT04608552: Effect of Myofunctional Therapy on OSA
Official title: Effect of Myofunctional Therapy on Outcomes in Mild to Moderate Sleep Apnea
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Sleep Apnea
Myofunctional Therapy
Chronic Disease
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-10-29
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Apnea Hypopnea Index (AHI; measure of sleep apnea disease severity)
timeFrame: 3 months and 6 months
Secondary outcomes:
measure: Change in Functional Outcomes of Sleep Questionnaire (FOSQ; measure of daytime functioning)
timeFrame: 3 months and 6 months
measure: Change in Epworth Sleepiness Score (ESS; measure of sleepiness)
timeFrame: 3 months and 6 months
measure: Change in Pittsburgh Sleep Quality Index (PSQI; measure of sleep quality)
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Carl J Stepnowsky, Jr., PhD
role: PRINCIPAL_INVESTIGATOR
References: