Telemedicine Interventions for Obstructive Sleep Apnea (OSA)

This study is currently recruiting participants.
Verified February 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01108081
First received: April 20, 2010
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Sleep Apnea
Behavioral: Physical activity
Behavioral: Diet
Behavioral: Health education
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: An RCT of Telemedicine Interventions for OSA

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Sleep symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 216
Study Start Date: October 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Physical activity
Behavioral: Physical activity
Moderate-intensity physical activity
Experimental: Arm 2
Diet
Behavioral: Diet
Dietary weight loss
Active Comparator: Arm 3
Health education
Behavioral: Health education
Attention control intervention

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:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108081

Contacts
Contact: David W Sparrow, DSc (857) 364-6400 ext 46400 David.Sparrow@va.gov

Locations
United States, Massachusetts
VA Boston Health Care System Recruiting
Boston, Massachusetts, United States, 02130
Contact: David W Sparrow, DSc    (857) 364-6400 ext 46400    David.Sparrow@va.gov   
Principal Investigator: David William Sparrow, DSc         
Sponsors and Collaborators
Investigators
Principal Investigator: David William Sparrow, DSc VA Boston Health Care System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01108081     History of Changes
Other Study ID Numbers: IIR 09-063
Study First Received: April 20, 2010
Last Updated: February 7, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Sleep apnea
Sleep symptoms
Quality of Life

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 15, 2014