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NCT00682838 Clinical Trial

Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring

Sleep Apnea Syndromes Clinical Trial

Official title:
Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00682838
Other study ID # IIR 07-163
Secondary ID 080139
Status Completed
Phase Phase 2/Phase 3
First received May 12, 2008
Last updated August 11, 2014
Start date July 2009
Est. completion date June 2012

Study information
Verified date August 2014
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

Obstructive sleep apnea (OSA) is a major chronic condition affecting the quality of life of up to one-fifth of all Veterans. Because of disappointingly low adherence to the gold-standard treatment (continuous positive airway pressure therapy - CPAP), the Institute of Medicine has stated that new adherence strategies are needed that improve the quality of care, reduce social and economic costs, and help OSA patients live happier, healthier, and more productive lives through improved clinical management. The combination of a self-management approach along with emerging wireless technologies has strong potential to increase treatment adherence and improve outcomes.

Description:

Obstructive sleep apnea (OSA) is a major chronic condition affecting the quality of life of up to one-fifth of all Veterans. Because of disappointingly low adherence to the gold-standard treatment (continuous positive airway pressure therapy - CPAP), the Institute of Medicine has stated that new adherence strategies are needed that improve the quality of care, reduce social and economic costs, and help OSA patients live happier, healthier, and more productive lives through improved clinical management. The combination of a self-management approach along with emerging wireless technologies has strong potential to increase treatment adherence and improve outcomes.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date June 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosed with obstructive sleep apnea

- Live in San Diego County

- Veteran

Exclusion Criteria:

- Previous use of positive airway therapy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Self-management
Self-management
• Telemonitored care
Telemonitored care

Locations
Country Name City State
United States VA San Diego Healthcare System San Diego California

Sponsors (2)
Lead Sponsor Collaborator
VA Office of Research and Development University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Treatment adherence 3 mos No
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