Melatonin and Sleep in Preventing Delirium in the Hospital
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Delirium
In brief
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).
Key facts
- Study ID
- NCT02597231
- Run by
- Scripps Health
- People needed
- 94
- Starts
- 2015-11-01
- Expected to finish
- 2016-12-31
- Last updated by the study team
- 2017-10-04
Who can join
Age: 65 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 65-100 years old
- Admitted to Scripps Green Hospital
- Admitted to an Internal Medicine or Medicine Consult Service
- Expected to have a hospital stay of greater than or equal to 48 hours (patients admitted to "inpatient," not "observation," under Medicare guidelines)
You may not qualify if…
- Cirrhosis of any etiology
- Admitted for alcohol withdrawal
- Currently taking a 1st or 2nd generation anti-psychotic
- Active delirium (i.e., delirium prior to 1st dose of melatonin)
- Diagnosis of encephalitis
- History of seizure
Where it is running
- Scripps Green Hospital — La Jolla, California, United States
Full record on ClinicalTrials.gov
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