Effect of Myofunctional Therapy on OSA

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Behavioral: OMT Exercises
* Behavioral: Nasal Breathing Exercises
* Other: Use of Nasal Lavage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Myofunctional Therapy<br>Active Myofunctional Therapy is comprised of five 30-minute weekly sessions for 4 weeks. | Behavioral: OMT Exercises<br>* Oral and oropharyngeal exercises<br>|
| Sham Comparator: Inactive Myofunctional Therapy<br>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. | Behavioral: Nasal Breathing Exercises<br>* Nasal breathing exercises each week<br>Other: Use of Nasal Lavage<br>* Use of nasal lavage with application of 10ml of saline in each nostril two times per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Apnea Hypopnea Index (AHI; measure of sleep apnea disease severity) | 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. | 3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functional Outcomes of Sleep Questionnaire (FOSQ; measure of daytime functioning) | Compare the change in FOSQ between OMT and inactive OMT groups over the follow-up time points. Higher FOSQ scores indicate improved levels of daytime functioning. | 3 months and 6 months | 
| Change in Epworth Sleepiness Score (ESS; measure of sleepiness) | Change in ESS between OMT and inactive OMT groups over the follow-up time points. Higher ESS scores indicate higher sleepiness levels. | 3 months and 6 months | 
| Change in Pittsburgh Sleep Quality Index (PSQI; measure of sleep quality) | Change in PSQI between OMT and inactive OMT groups over the follow-up time points. Higher PSQI scores indicate worse sleep quality. | 3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep Apnea, Myofunctional Therapy, Chronic Disease