Clinical trial NCT01108081: Telemedicine Interventions for Obstructive Sleep Apnea (OSA)
Official title: An RCT of Telemedicine Interventions for OSA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sleep Apnea
Keywords: Sleep apnea
Sleep symptoms
Quality of Life
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-04-21
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change Over 6 Months in Epworth Sleepiness Scale Score
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Change Over 6 Months in Quality of Life
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: David W Sparrow, DSc
role: PRINCIPAL_INVESTIGATOR
References: