Telemedicine Interventions for Obstructive Sleep Apnea (OSA)

Study Overview
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Brief Summary
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This project is investigating whether both moderate-intensity physical activity and dietary weight loss will independently reduce sleep apnea symptoms and improve quality of life.

Detailed Description
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Background/Rationale: Obstructive sleep apnea/hypopnea (OSAH) is a common chronic disease that is associated with daytime sleepiness, impaired health-related quality of life (QOL), and increased risk of hypertension and cardiovascular disease. The most common treatment is continuous positive airway pressure (CPAP), although adherence to CPAP is poor in more than one-third of patients. Weight loss can clearly lessen the severity of OSAH, but although short-term dietary weight loss can often be achieved it is difficult to maintain. Regular aerobic exercise is associated with a lower prevalence of OSAH in observational studies after adjustment for body habitus, and in two small clinical trials moderate exercise was associated with a substantial decrease in OSAH severity despite little or no weight loss. Demonstrating that dietary weight loss and moderate physical activity, promoted in the home setting, independently improve OSAH severity will have a major impact on the therapeutic approach to OSAH, a disease that is highly prevalent in the VA population. Objective: The investigators hypothesize that both moderate-intensity physical activity and dietary weight loss will independently reduce OSAH severity and improve QOL. Methods: The proposed study is a randomized clinical trial designed to test the independent effects of the physical activity and diet interventions, with an attention control intervention for subjects not assigned to either active intervention. Subjects will be male and female Veterans with a BMI over 24 kg/m2, with a physician diagnosis of OSAH and apnea-hypopnea index (AHI) >10/hr. The interventions will last six months.

Official Title
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An RCT of Telemedicine Interventions for OSA

Conditions
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Sleep Apnea

Intervention / Treatment
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* Behavioral: Physical activity
* Behavioral: Diet
* Behavioral: Health education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physician diagnosis of sleep apnea Apnea-hypopnea index >10/hr BMI over 24 kg/m2 Exclusion Criteria: Angina pectoris History of myocardial infarction within 6 months

Ages Eligible for Study
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Minimum Age: 18 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

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Physical activity | Behavioral: Physical activity<br>* Moderate-intensity physical activity<br>|
| Experimental: Arm 2<br>Diet | Behavioral: Diet<br>* Dietary weight loss<br>|
| Active Comparator: Arm 3<br>Health education | Behavioral: Health education<br>* Attention control intervention<br>|
| Experimental: Arm 4<br>Combined physical activity and diet | Behavioral: Physical activity<br>* Moderate-intensity physical activity<br>Behavioral: Diet<br>* Dietary weight loss<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change Over 6 Months in Epworth Sleepiness Scale Score | Epworth Sleepiness Scale score, change in score from baseline to 6 months. Total scores range from 0-24, where higher scores indicate more sleepiness. | baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change Over 6 Months in Quality of Life | Quality of life as assessed by the Functional Outcomes of Sleep Questionnaire, change from baseline to 6 months. The potential range of scores for the Functional Outcomes of Sleep total score is 5-20 where higher scores indicate better quality of life. The total score is the sum of the 5 subscale scores (general productivity, social outcome, activity level, vigilance, intimate relationships), which are weighted means ranging from 1-4. | baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep apnea, Sleep symptoms, Quality of Life