Melatonin and Sleep in Preventing Delirium in the Hospital
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 65 - 100 |
| Updated: | 10/6/2017 |
| Start Date: | November 2015 |
| End Date: | December 31, 2016 |
Melatonin and Sleep in Preventing Delirium in the Hospital: A Randomized Placebo-controlled Trial
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).
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).
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
We found this trial at
1
site
La Jolla, California 92037
Principal Investigator: Thomas McCarthy, MD
Phone: 858-554-5743
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