Effect of Self-Management on Improving Sleep Apnea Outcomes

Sleep Apnea Syndromes Clinical Trial

Official title:

Effect of Self-Management on Improving Sleep Apnea Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00310310
• Other study ID #: IIR 02-275
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 30, 2006
• Last updated: July 14, 2014
• Start date: April 2006
• Est. completion date: December 2009

Study information

• Verified date: July 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes

Intervention

Behavioral:
• Sleep Apnea Self-Management Program
Sleep apnea self-management program - 4 sessions, group-based.
• Usual care
Usual sleep apnea and cpap care

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (3)

Stepnowsky CJ, Ancoli-Israel S. Sleep and Its Disorders in Seniors. Sleep Med Clin. 2008;3(2):281-293. — View Citation

Stepnowsky CJ, Palau JJ, Gifford AL, Ancoli-Israel S. A self-management approach to improving continuous positive airway pressure adherence and outcomes. Behav Sleep Med. 2007;5(2):131-46. — View Citation

Stepnowsky CJ, Palau JJ, Marler MR, Gifford AL. Pilot randomized trial of the effect of wireless telemonitoring on compliance and treatment efficacy in obstructive sleep apnea. J Med Internet Res. 2007 May 17;9(2):e14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CPAP adherence		6 months	No
Secondary	Perceived self-efficacy, outcome expectations and reduced sleep apnea symptoms at post-intervention		6 months	No