Effect of Self-Management on Improving Sleep Apnea Outcomes
1 other identifier
interventional
240
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2006
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2006
CompletedStudy Start
First participant enrolled
April 1, 2006
CompletedFirst Posted
Study publicly available on registry
April 3, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
March 22, 2017
CompletedApril 20, 2017
March 1, 2017
3.1 years
March 30, 2006
December 23, 2014
March 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
CPAP Adherence
The investigators examined the data obtained in the Sleep Apnea Self-Management Program at the one-month time point relative to participation in the Usual Care group.
1 month
CPAP Adherence
The investigators also examined the data obtained at the 6-month time point.
6 months
Secondary Outcomes (2)
Pittsburgh Sleep Quality Index (PSQI)
1 Month
Pittsburgh Sleep Quality Index (PSQI)
6 Months
Other Outcomes (6)
Sleep Apnea Quality of Life Index (SAQLI)
1 month
Quality of Well Being Scale (QWB-SA)
1 month
Self-Efficacy
1 month
- +3 more other outcomes
Study Arms (2)
Usual Care
PLACEBO COMPARATORUsual sleep apnea and cpap care
Self-Management
EXPERIMENTALsleep apnea self-management program - 4 sessions, group-based
Interventions
Sleep apnea self-management program - 4 sessions, group-based.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of obstructive sleep apnea
- No previous use of CPAP
- Must be a Veteran with residence within San Diego County
You may not qualify if:
- Home oxygen therapy
- Fatal comorbidities (i.e., life expectancy less than 6 mos)
- Contraindications for CPAP use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA San Diego Healthcare System
San Diego, California, 92161, United States
Related Publications (4)
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. doi: 10.1080/15402000701190622.
PMID: 17441783RESULTStepnowsky 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. doi: 10.2196/jmir.9.2.e14.
PMID: 17513285RESULTStepnowsky CJ, Ancoli-Israel S. Sleep and Its Disorders in Seniors. Sleep Med Clin. 2008;3(2):281-293. doi: 10.1016/j.jsmc.2008.01.011. No abstract available.
PMID: 19122865RESULTDeering S, Liu L, Zamora T, Hamilton J, Stepnowsky C. CPAP Adherence is Associated With Attentional Improvements in a Group of Primarily Male Patients With Moderate to Severe OSA. J Clin Sleep Med. 2017 Dec 15;13(12):1423-1428. doi: 10.5664/jcsm.6838.
PMID: 29065955DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Carl J. Stepnowsky,PhD
- Organization
- VA San Diego Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
Carl J Stepnowsky, PhD
San Diego Veterans Healthcare System
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2006
First Posted
April 3, 2006
Study Start
April 1, 2006
Primary Completion
May 1, 2009
Study Completion
December 1, 2009
Last Updated
April 20, 2017
Results First Posted
March 22, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share