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NCT00310310 · ClinicalTrials.gov registry record · Phase 2
Effect of Self-Management on Improving Sleep Apnea Outcomes
A Phase 2 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 240
- Enrollment target
NCT00310310: Completed Phase 2 study, sponsored by VA Office of Research and Development.
NCT00310310 is a Phase 2 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 240 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00310310, a Phase 2 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 240 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Usual care
- BEHAVIORAL Sleep Apnea Self-Management Program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2006-04 |
| Est. Completion | 2009-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00310310
The ClinicalTrials.gov registry entry for NCT00310310 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Usual care is the first listed.
NCT00310310 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00310310 about?
NCT00310310 is a clinical study titled "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 noctur...
What is the current status of trial NCT00310310?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 240 participants. The study started on 2006-04. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00310310?
The interventions under investigation include: Usual care (BEHAVIORAL), Sleep Apnea Self-Management Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT00310310?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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