Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring - Full Text View

Sponsors and Collaborators:	Department of Veterans Affairs University of California, San Diego
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00682838

Purpose

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.

Condition	Intervention	Phase
Sleep Apnea Syndromes	Behavioral: Self-management Behavioral: Telemonitored care	Phase II Phase III

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Treatment adherence [ Time Frame: 4 mos ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	December 2008
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Active Intervention	Behavioral: Self-management Self-management
2: Active Comparator Active Comparator	Behavioral: Telemonitored care Telemonitored care
3: Experimental 1+2	Behavioral: Self-management Self-management Behavioral: Telemonitored care Telemonitored care
4: No Intervention Usual care

Detailed Description:

Obstructive sleep apnea (OSA) is a major chronic condition fecting 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosed with obstructive sleep apnea

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682838

Contacts

Contact: Tania Zamora	(858) 552-8585 ext 5954	tania.zamora@va.gov
Contact: Christine Kezirian	(858) 552-8585	christine.kezirian@va.gov

Locations

United States, California
VA San Diego Healthcare System
San Diego, California, United States, 92161

Sponsors and Collaborators

Department of Veterans Affairs

University of California, San Diego

Investigators

Principal Investigator:

Carl J. Stepnowsky, PhD

VA San Diego Healthcare System

More Information

No publications provided

Responsible Party:	Department of Veterans Affairs ( Stepnowsky, Carl - Principal Investigator )
Study ID Numbers:	IIR 07-163, 080139
Study First Received:	May 12, 2008
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00682838 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Treatment compliance
Self-management
Telemedicine

Study placed in the following topic categories:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders

Sleep Apnea, Obstructive
Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Sleep Apnea Syndromes
Disease
Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Nervous System Diseases
Dyssomnias

Sleep Disorders
Sleep Disorders, Intrinsic
Signs and Symptoms
Pathologic Processes
Respiratory Tract Diseases
Syndrome
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on May 07, 2009