CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 240 enrolled
Drug / intervention
Sleep Apnea Self-Management Program +1 morebehavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00310310
NCT00310310Phase 3Completed

Effect of Self-Management on Improving Sleep Apnea Outcomes

VA Office of Research and Development·interventional·Posted Apr 3, 2006·Updated Apr 20, 2017

In Brief

A Phase 3 clinical trial evaluating Sleep Apnea Self-Management Program and Usual care for Sleep Apnea Syndromes. Completed, enrolled 240 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 3, 2006
Enrollment StartApr 1, 2006
Primary CompletionMay 1, 2009
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 20.2 years ago

Interventions

Sleep Apnea Self-Management Programbehavioral

Sleep apnea self-management program - 4 sessions, group-based.

Usual carebehavioral

Usual sleep apnea and cpap care