| March 30, 2006 |
| September 25, 2009 |
| April 2006 |
| May 2009 (final data collection date for primary outcome measure) |
| CPAP adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ] |
| CPAP adherence at 6 months |
| Complete list of historical versions of study NCT00310310 on ClinicalTrials.gov Archive Site |
| Perceived self-efficacy, outcome expectations and reduced sleep apnea symptoms at post-intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ] |
| Perceived self-efficacy, outcome expectations and reduced sleep apnea symptoms at post-intervention |
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| Effect of Self-Management on Improving Sleep Apnea Outcomes |
| Effect of Self-Management on Improving Sleep Apnea Outcomes |
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. |
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. |
| Phase II, Phase III |
| Interventional |
| Other, Randomized, Single Blind (Subject), Active Control, Single Group Assignment, Efficacy Study |
| Sleep Apnea Syndromes |
- Behavioral: Sleep Apnea Self-Management Program
- Behavioral: Usual care
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- Placebo Comparator: Usual sleep apnea and cpap care
- Experimental: sleep apnea self-management program - 4 sessions, group-based
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| Active, not recruiting |
| 240 |
| March 2010 |
| May 2009 (final data collection date for primary outcome measure) |
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
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| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00310310 |
| Stepnowsky, Carl - Principal Investigator, Department of Veterans Affairs |
| IIR 02-275, UCSD HRPP #050717 |
| Department of Veterans Affairs |
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| Principal Investigator: |
Carl J. Stepnowsky, PhD |
VA San Diego Healthcare System |
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| Department of Veterans Affairs |
| September 2009 |