Telemedicine Interventions for Obstructive Sleep Apnea (OSA)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sleep Apnea |
Behavioral: Physical activity Behavioral: Diet Behavioral: Health education |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Outcomes Assessor) |
| Official Title: | An RCT of Telemedicine Interventions for OSA |
- Sleep symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 216 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Physical activity
|
Behavioral: Physical activity
Moderate-intensity physical activity
|
|
Experimental: Arm 2
Diet
|
Behavioral: Diet
Dietary weight loss
|
|
Active Comparator: Arm 3
Health education
|
Behavioral: Health education
Attention control intervention
|
Detailed Description:
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:
We 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: David W Sparrow, DSc | (857) 364-6400 ext 46400 | David.Sparrow@va.gov |
| United States, Massachusetts | |
| VA Boston Health Care System | Recruiting |
| Boston, Massachusetts, United States, 02130 | |
| Contact: David W Sparrow, DSc (857) 364-6400 ext 46400 David.Sparrow@va.gov | |
| Principal Investigator: David William Sparrow, DSc | |
| Principal Investigator: | David William Sparrow, DSc | VA Boston Health Care System |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01108081 History of Changes |
| Other Study ID Numbers: | IIR 09-063 |
| Study First Received: | April 20, 2010 |
| Last Updated: | February 15, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Sleep apnea Sleep symptoms Quality of Life |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013