Telemedicine Interventions for Obstructive Sleep Apnea (OSA)

Sleep Apnea Clinical Trial

Official title:

An RCT of Telemedicine Interventions for OSA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01108081
• Other study ID #: IIR 09-063
• Status: Completed
• Phase: Phase 3
• First received: April 20, 2010
• Last updated: July 7, 2016
• Start date: October 2010
• Est. completion date: January 2016

Study information

• Verified date: July 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Behavioral:
• Physical activity
Moderate-intensity physical activity
• Diet
Dietary weight loss
• Health education
Attention control intervention

Locations

Country	Name	City	State
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep symptoms		6 months	No
Secondary	Quality of life		6 months	No