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NCT02597231 · ClinicalTrials.gov registry record · Phase 1
Melatonin and Sleep in Preventing Delirium in the Hospital
A Phase 1 study, sponsored by Scripps Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 94
- Enrollment target
NCT02597231: Completed Phase 1 study, sponsored by Scripps Health.
NCT02597231 is a Phase 1 study that has completed, run by Scripps Health. The registered enrollment target is 94 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02597231, a Phase 1 study, has completed, sponsored by Scripps Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 94 participants
- Enrollment target
Study Summary
Recent data suggests that melatonin, a supplement available over the counter, may help prevent delirium in hospitalized patients. The investigators are hypothesizing that melatonin may help in delirium prevention by improving sleep quality and possibly circadian rhythm cycling in patients who are given the supplement. This pilot study involves a randomized placebo-controlled design in which participants will be randomized to receive either melatonin 3mg orally or placebo orally. Participants in both groups will be fitted with wireless actigraphy devices to obtain objective sleep quality, and will also receive a sleep questionnaire each morning to obtain subjective data on their sleep quality overnight. Delirium will be assessed by floor nurses twice daily using the Confusion Assessment Method (CAM).
Primary Outcome
Primary outcome is whether patients become delirious, as measured by CAM during their hospital admission.
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT Melatonin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2015-11 |
| Est. Completion | 2016-12-31 |
| Phase | Phase 1 |
What the finished NCT02597231 record still lists
NCT02597231 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02597231 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02597231 about?
NCT02597231 is a clinical study titled "Melatonin and Sleep in Preventing Delirium in the Hospital". Recent data suggests that melatonin, a supplement available over the counter, may help prevent delirium in hospitalized patients. The investigators are hypothesizing that melatonin may help in delirium prevention by improving sleep quality and possibly circadian rhythm cycling in patients who are gi...
What is the current status of trial NCT02597231?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 94 participants. The study started on 2015-11. Estimated completion is 2016-12-31.
What interventions are being tested in trial NCT02597231?
The interventions under investigation include: Placebo (OTHER), Melatonin (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02597231?
This trial is sponsored by Scripps Health, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02597231's enrollment target sits among peer trials
94 615th of 2000 higher than 1,377 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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