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Melatonin and Sleep in Preventing Delirium in the Hospital

NCT02597231 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2017-10-04

No results posted yet for this 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).

Conditions

  • Delirium

Interventions

DIETARY_SUPPLEMENT

Melatonin

Melatonin is the dietary supplement we are using in delirium prevention.

OTHER

Placebo

Patients in this group will receive a matching placebo pill.

Sponsors & Collaborators

  • Scripps Clinic

    collaborator OTHER

  • Scripps Health

    lead OTHER

Principal Investigators

  • Thomas McCarthy, MD · Scripps Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02597231 on ClinicalTrials.gov