Effect of Myofunctional Therapy on OSA
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Active Myofunctional Therapy Active Myofunctional Therapy is comprised of five 30-minute weekly sessions for 4 weeks. |
Behavioral: OMT Exercises
Oral and oropharyngeal exercises
|
| Sham Comparator: Inactive Myofunctional Therapy 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
Nasal breathing exercises each week
Other: Use of Nasal Lavage
Use of nasal lavage with application of 10ml of saline in each nostril two times per day
|
Outcome Measures
Primary Outcome Measures
- Change in Apnea Hypopnea Index (AHI; measure of sleep apnea disease severity) [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 Outcome Measures
- Change in Functional Outcomes of Sleep Questionnaire (FOSQ; measure of daytime functioning) [3 months and 6 months]
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.
- Change in Epworth Sleepiness Score (ESS; measure of sleepiness) [3 months and 6 months]
Change in ESS between OMT and inactive OMT groups over the follow-up time points. Higher ESS scores indicate higher sleepiness levels.
- Change in Pittsburgh Sleep Quality Index (PSQI; measure of sleep quality) [3 months and 6 months]
Change in PSQI between OMT and inactive OMT groups over the follow-up time points. Higher PSQI scores indicate worse sleep quality.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Mild-to-moderate OSA
-
Entry criteria are as inclusive as possible and operationalized as follows: age>18 years old
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Confirmed diagnosis of OSA
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Having chronic symptoms per screening symptom checklist
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Fluency in English
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receiving medical care at VA San Diego Healthcare System
Exclusion Criteria:
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Cognitive impairment sufficient to cause inability to complete the protocol (per medical chart review)
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Low health literacy
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Residence in a geographical area outside of San Diego County
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Fatal comorbidity (life expectancy <6 months as indicated by treating physician)
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Significant documented substance/chemical abuse
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA San Diego Healthcare System, San Diego, CA | San Diego | California | United States | 92161 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Carl J Stepnowsky, Jr., PhD, VA San Diego Healthcare System, San Diego, CA
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D2651-R