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Effect of Self-Management on Improving Sleep Apnea Outcomes

This study is currently recruiting participants.
Verified by Department of Veterans Affairs, January 2008

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
Behavioral: Sleep Apnea Self-Management Program
Phase II
Phase III

MedlinePlus related topics:   Coping with Chronic Illness    Sleep Apnea   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, 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 Outcome Measures:
  • CPAP adherence at 6 months

Secondary Outcome Measures:
  • Perceived self-efficacy, outcome expectations and reduced sleep apnea symptoms at post-intervention

Estimated Enrollment:   160
Study Start Date:   April 2006
Estimated Study Completion Date:   April 2009

Detailed Description:

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 older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Clinical diagnosis of obstructive sleep apnea
  • No previous use of CPAP
  • Must be a Veteran with residence within San Diego County

Exclusion Criteria:

  • Home oxygen therapy
  • Fatal comorbidities (i.e., life expectancy less than 6 mos)
  • Contraindications for CPAP use
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310310

Contacts
Contact: Tania Zamora     (858) 552-8585 ext 5954     tania.zamora@va.gov    
Contact: Joseph J Palau, BA     (858) 552-8585 ext 3054     joe.palau@va.gov    

Locations
United States, California
VA San Diego Healthcare System     Recruiting
      San Diego, California, United States, 92161
      Contact: ART Program         ART@va.gov    
      Principal Investigator: Carl J. Stepnowsky, PhD BS            

Sponsors and Collaborators

Investigators
Principal Investigator:     Carl J. Stepnowsky, PhD BS     VA San Diego Healthcare System    
  More Information

Study ID Numbers:   IIR 02-275, UCSD HRPP #050717
First Received:   March 30, 2006
Last Updated:   January 4, 2008
ClinicalTrials.gov Identifier:   NCT00310310
Health Authority:   United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Continuous positive airway pressure  
Patient compliance  
Self-care  

Study placed in the following topic categories:
Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders
Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome
Nervous System Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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