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Completed

NCT Number: NCT01108081

Telemedicine Interventions for Obstructive Sleep Apnea (OSA)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Boston, Massachusetts, 02130, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity

Behavioral

Moderate-intensity physical activity

Diet

Behavioral

Dietary weight loss

Health Education

Behavioral

Attention control intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

An RCT of Telemedicine Interventions for OSA

Important dates

Study start
2010
Primary completion
2015
Study completion
2016
First posted
Apr 21, 2010
Registry last updated
Feb 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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