View Clinical Trial (Medical Research Study)
An RCT of Telemedicine Interventions for OSA
| City: |
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02130 |
| Conditions: |
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Sleep Apnea |
| Purpose: |
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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.
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| Study Summary: |
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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:
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.
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| 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
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| NCT ID: |
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NCT01108081 |
| Primary Contact: |
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Principal Investigator
David William Sparrow, DSc
VA Boston Health Care System
David W Sparrow, DSc
Phone: (857) 364-6400 ext. 46400
Email: David.Sparrow@va.gov
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| Backup Contact: |
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N/A |
| Location Contact: |
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Boston, Massachusetts 02130
United States
David W Sparrow, DSc
Phone: (857) 364-6400
Email: David.Sparrow@va.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
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