Sponsor study identifier
interventional
240
1 country
1
Study Start
April 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2009
Actual (reported)Study Completion
December 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 30, 2006
Actual (reported)April 2006
Date type not reportedThis date has not been verified as actual or estimated.
April 3, 2006
Actual (reported)May 2009
Actual (reported)December 2009
Actual (reported)March 22, 2017
Actual (reported)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
Pittsburgh Sleep Quality Index (PSQI)
1 Month
Pittsburgh Sleep Quality Index (PSQI)
6 Months
Sleep Apnea Quality of Life Index (SAQLI)
1 month
Quality of Well Being Scale (QWB-SA)
1 month
Self-Efficacy
1 month
Usual sleep apnea and cpap care
sleep apnea self-management program - 4 sessions, group-based
Sleep apnea self-management program - 4 sessions, group-based.
Usual sleep apnea and cpap care
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
VA San Diego Healthcare System
San Diego, California, 92161, United States
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.
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. doi: 10.2196/jmir.9.2.e14.
Carl J Stepnowsky, PhD
San Diego Veterans Healthcare System
240 participants (actual enrollment reported by the registry).
First Submitted
March 30, 2006
First Posted
April 3, 2006
Study Start
April 2006
Date type not reportedThis date has not been verified as actual or estimated.
A Pilot Study of CPAP Adherence Promotion by Peer Buddies With Sleep Apnea
Respiratory and Autonomic Plasticity Following Intermittent Hypoxia
Contact the study team to confirm eligibility.
Stepnowsky 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.
Deering 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.
Primary Completion
May 2009
Actual (reported)Study Completion
December 2009
Actual (reported)Last Updated
April 20, 2017
Results First Posted
March 22, 2017
Record last verified: 2017-03
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Source: ClinicalTrials.gov.
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