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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Myofunctional Therapy | Active Comparator | Active Myofunctional Therapy is comprised of five 30-minute weekly sessions for 4 weeks. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OMT Exercises | Behavioral | Oral and oropharyngeal exercises |
| |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carl J Stepnowsky, Jr., PhD | VA San Diego Healthcare System, San Diego, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System, San Diego, CA | San Diego | California | 92161-0002 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 10, 2023 | Aug 6, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| Nasal Breathing Exercises |
| Behavioral |
Nasal breathing exercises each week |
|
| Use of Nasal Lavage | Other | Use of nasal lavage with application of 10ml of saline in each nostril two times per day |
|
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 |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |