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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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% higher). 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.
Primary Outcome
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.
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 |
What the finished NCT00310310 record still lists
NCT00310310 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% higher).
The record links to 0 conditions, and to 2 interventions - of which Usual care is the first listed.
NCT00310310 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00310310's enrollment target sits among peer trials
240 239th of 2000 higher than 1,746 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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