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Effect of Self-Management on Improving Sleep Apnea Outcomes

This study is currently recruiting patients

Verified by Department of Veterans Affairs July 2006

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00310310


Purpose

Obstructive sleep apnea syndrome (OSA) is a common sleep disorder that is associated with serious medical and psychological complications. Nasal continuous positive airway pressure (CPAP) is the treatment of choice for this condition because it is highly effective in reducing the frequency of nocturnal respiratory events, improving sleep architecture, decreasing daytime sleepiness and improving blood pressure. Incomplete patient adherence, however, limits the effectiveness of CPAP therapy and results in sub-optimal patient outcomes. Previous efforts to enhance CPAP adherence have resulted in only modest improvements, have generally not been theory-driven, and have had minimal effects on key patient outcomes such as reduction in OSA symptoms or increase in health-related quality of life (HRQOL). The planned intervention in this proposal, the Sleep Apnea Self-Management Program (SASMP), is based on the rationale that sleep apnea is a chronic disease that requires significant self-care on the part of the patient. We draw on the extensive chronic disease self-management literature to provide a solid theoretical justification for this pragmatic intervention both to better manage key aspects of OSA and to increase CPAP adherence. Chronic disease management programs help reduce symptoms, improve HRQOL, improve treatment adherence, and decrease medical utilization.


Condition Intervention Phase
Sleep Apnea Syndromes Behavior: Sleep Apnea Self-Management Program Phase II
Phase III

Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study

Official Title: Effect of Self-Management on Improving Sleep Apnea Outcomes

Further study details as provided by Department of Veterans Affairs:
Primary Outcomes: CPAP adherence at 6 months
Secondary Outcomes: Perceived self-efficacy, outcome expectations and reduced sleep apnea symptoms at post-intervention
Expected Total Enrollment:  160

Study start: April 2006;  Expected completion: September 2009
Last follow-up: April 2009;  Data entry closure: June 2009

Background: Obstructive sleep apnea syndrome (OSA) is a common sleep disorder that is associated with serious medical and psychological complications. Nasal continuous positive airway pressure (CPAP) is the treatment of choice for this condition because it is highly effective in reducing the frequency of nocturnal respiratory events, improving sleep architecture, decreasing daytime sleepiness and improving blood pressure. Incomplete patient adherence, however, limits the effectiveness of CPAP therapy and results in sub-optimal patient outcomes. Previous efforts to enhance CPAP adherence have resulted in only modest improvements, have generally not been theory-driven, and have had minimal effects on key patient outcomes such as reduction in OSA symptoms or increase in health-related quality of life (HRQOL). The planned intervention in this proposal, the Sleep Apnea Self-Management Program (SASMP), is based on the rationale that sleep apnea is a chronic disease that requires significant self-care on the part of the patient. We draw on the extensive chronic disease self-management literature to provide a solid theoretical justification for this pragmatic intervention both to better manage key aspects of OSA and to increase CPAP adherence. Chronic disease management programs help reduce symptoms, improve HRQOL, improve treatment adherence, and decrease medical utilization. Objectives: The primary aim of this study is to compare the efficacy of the SASMP to Usual Care for improving OSA symptom status, HRQOL, and self-reported medical utilization. A second aim is to examine the extent to which changes in symptoms and HRQOL are mediated by changes in self-efficacy and CPAP adherence. Methods: We will evaluate the Sleep Apnea Self-Management Program (SASMP) by conducting a randomized, controlled trial of the program compared to Usual Care in patients diagnosed with OSA and prescribed CPAP therapy. Participants randomized to the SASMP group will attend 4 weekly educational sessions of 2.5 hours each. Two trained leaders facilitate the program from a scripted manual. Key topics covered in this program include 1) management of OSA symptoms, CPAP side effects, and weight loss; 2) maintaining social contacts and family relationships; and 3) dealing with symptoms of depression and worries about the future. Findings: No results at this time. Status: We are currently engaging in start-up activities. Impact: The results of this project can improve service delivery and improve health outcomes for sleep apnea patients at the Veterans Affairs San Diego Healthcare System, throughout the VA, as well as to any community based sleep clinic.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both Criteria

Inclusion Criteria:

clinical diagnosis of obstructive sleep apnea, no previous use of CPAP, age greater than or equal to 18 years, and must be a Veteran with residence within San Diego County.

Exclusion Criteria:

Home oxygen therapy; fatal comorbidities (ie life expectancy less than 6 mos); contraindications for CPAP use

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00310310

Joseph J Palau, BA      (858) 552-8585  Ext. 3054    joe.palau@va.gov
Carl J Stepnowsky, PhD BS      (858) 552-8585  Ext. 5948    cstepnowsky@ucsd.edu

California
VA San Diego Healthcare System, San Diego,  California,  92161,  United States; Recruiting
Joseph J Palau, BA  858-552-8585  Ext. 3054    joe.palau@va.gov 
Carl J Stepnowsky, PhD BS  (858) 552-8585  Ext. 5948    cstepnowsky@ucsd.edu 
Carl J. Stepnowsky, PhD BS,  Principal Investigator

Study chairs or principal investigators
Carl J. Stepnowsky, PhD BS,  Principal Investigator,  VA San Diego Healthcare System   

More Information

Study ID Numbers:  IIR 02-275; UCSD HRPP #050717
Last Updated:  July 24, 2006
Record first received:  March 30, 2006
ClinicalTrials.gov Identifier:  NCT00310310
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-09-29





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