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Telemedicine Interventions for Obstructive Sleep Apnea (OSA)

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ClinicalTrials.gov Identifier: NCT01108081
Recruitment Status : Completed
First Posted : April 21, 2010
Results First Posted : February 10, 2017
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Behavioral: Physical activity Behavioral: Diet Behavioral: Health education Phase 3

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 169 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Official Title: An RCT of Telemedicine Interventions for OSA
Study Start Date : October 2010
Primary Completion Date : November 2015
Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
Experimental: Arm 4
Combined physical activity and diet
Behavioral: Physical activity
Moderate-intensity physical activity
Behavioral: Diet
Dietary weight loss


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108081


Locations
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: David W Sparrow, DSc VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01108081     History of Changes
Other Study ID Numbers: IIR 09-063
First Posted: April 21, 2010    Key Record Dates
Results First Posted: February 10, 2017
Last Update Posted: February 10, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by VA Office of Research and Development:
Sleep apnea
Sleep symptoms
Quality of Life

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