Telemedicine Interventions for Obstructive Sleep Apnea (OSA)
An RCT of Telemedicine Interventions for OSA
Study Overview
Status
Conditions
Intervention / Treatment
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:
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02130
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1
Physical activity
|
Moderate-intensity physical activity
|
|
Experimental: Arm 2
Diet
|
Dietary weight loss
|
|
Active Comparator: Arm 3
Health education
|
Attention control intervention
|
|
Experimental: Arm 4
Combined physical activity and diet
|
Moderate-intensity physical activity
Dietary weight loss
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change Over 6 Months in Epworth Sleepiness Scale Score
Time Frame: baseline and 6 months
|
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
Time Frame: baseline and 6 months
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: David W Sparrow, DSc, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 09-063
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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