Telemedicine Interventions for Obstructive Sleep Apnea (OSA)

NCT ID: NCT01108081

Last Updated: 2017-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2016-01-31

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.

Conditions

Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Blinding Strategy: SINGLE

Study Groups

Arm 1

Physical activity

Group Type: EXPERIMENTAL

Physical activity

Intervention Type: BEHAVIORAL

Moderate-intensity physical activity

Arm 2

Diet

Group Type: EXPERIMENTAL

Diet

Intervention Type: BEHAVIORAL

Dietary weight loss

Arm 3

Health education

Group Type: ACTIVE_COMPARATOR

Health education

Intervention Type: BEHAVIORAL

Attention control intervention

Arm 4

Combined physical activity and diet

Group Type: EXPERIMENTAL

Physical activity

Intervention Type: BEHAVIORAL

Moderate-intensity physical activity

Diet

Intervention Type: BEHAVIORAL

Dietary weight loss

Interventions

Physical activity

Moderate-intensity physical activity

Intervention Type: BEHAVIORAL

Diet

Dietary weight loss

Intervention Type: BEHAVIORAL

Health education

Attention control intervention

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David W Sparrow, DSc

Role: PRINCIPAL_INVESTIGATOR

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Locations

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

IIR 09-063

Identifier Type: -

Identifier Source: org_study_id