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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 is a Phase 1 study that has completed, run by Scripps Health. The registered enrollment target is 94 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02597231
The ClinicalTrials.gov registry entry for NCT02597231 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Scripps Health, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02597231 reports 0 study locations.
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.
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