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NCT02458469 · ClinicalTrials.gov registry record · Phase 2
Role of Enhancing Serotonin Receptors Activity for Sleep Apnea Treatment in Patients With SCI
A Phase 2 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT02458469: Completed Phase 2 study, sponsored by VA Office of Research and Development.
NCT02458469 is a Phase 2 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02458469, a Phase 2 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
The purpose of this study is to look at the effect of exciting using drugs to target a specific pathway in the body, that relies on a natural chemical the body produces called 'serotonin', in patients with spinal cord injury (SCI) during sleep. During this part of the study participants will be asked to take buspirone (Buspar) (15-50mg per day), trazodone (100mg per day) and a placebo in a random fashion, each for a 2 week period (drug period) of time followed by two weeks without drugs (washout period). The drugs will not be taken all at the same time, but each will be taken separately for two weeks followed by a night study to look at the effect the medication/placebo pill has on the way the body responds during sleep.
Primary Outcome
Randomized placebo-controlled cross-over study. Each subject was studied on three separate occasions: (1) Buspirone vs. Trazodone vs. placebo for 2 weeks; After the two-week treatment a noninvasive nasal mechanical ventilation study was repeated to determine the hypocapnic apneic threshold. (2) Cross over medication for two weeks was followed by a second noninvasive nasal mechanical ventilation study to determine the CO2 reserve (Delta-PETCO2-AT) and hypocapnic apneic threshold followed by two w
Interventions
- DRUG Placebo
- DRUG Trazodone
- DRUG Buspirone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2015-05-14 |
| Est. Completion | 2019-04-12 |
| Phase | Phase 2 |
What the finished NCT02458469 record still lists
NCT02458469 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02458469 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02458469 about?
NCT02458469 is a clinical study titled "Role of Enhancing Serotonin Receptors Activity for Sleep Apnea Treatment in Patients With SCI". The purpose of this study is to look at the effect of exciting using drugs to target a specific pathway in the body, that relies on a natural chemical the body produces called 'serotonin', in patients with spinal cord injury (SCI) during sleep. During this part of the study participants will be aske...
What is the current status of trial NCT02458469?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2015-05-14. Estimated completion is 2019-04-12.
What interventions are being tested in trial NCT02458469?
The interventions under investigation include: Placebo (DRUG), Trazodone (DRUG), Buspirone (DRUG).
Who is sponsoring clinical trial NCT02458469?
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 NCT02458469's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 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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