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Melatonin and Sleep in Preventing Delirium in the Hospital

NCT ID: NCT02597231

Last Updated: 2017-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Melatonin Group

Patients in this group will receive melatonin 3mg orally at 9pm.

Group Type EXPERIMENTAL

Melatonin

Intervention Type DIETARY_SUPPLEMENT

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

Placebo Group

Patient in this group will receive a matching placebo pill orally at 9pm.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Patients in this group will receive a matching placebo pill.

Interventions

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Melatonin

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Patients in this group will receive a matching placebo pill.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Scripps Clinic

OTHER

Sponsor Role collaborator

Scripps Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas McCarthy, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Health

Locations

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Scripps Green Hospital

La Jolla, California, United States

Site Status

Countries

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United States

References

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Jaiswal SJ, Kang DY, Wineinger NE, Owens RL. Objectively measured sleep fragmentation is associated with incident delirium in older hospitalized patients: Analysis of data collected from an randomized controlled trial. J Sleep Res. 2021 Jun;30(3):e13205. doi: 10.1111/jsr.13205. Epub 2020 Oct 13.

Reference Type DERIVED
PMID: 33051948 (View on PubMed)

Jaiswal SJ, McCarthy TJ, Wineinger NE, Kang DY, Song J, Garcia S, van Niekerk CJ, Lu CY, Loeks M, Owens RL. Melatonin and Sleep in Preventing Hospitalized Delirium: A Randomized Clinical Trial. Am J Med. 2018 Sep;131(9):1110-1117.e4. doi: 10.1016/j.amjmed.2018.04.009. Epub 2018 May 3.

Reference Type DERIVED
PMID: 29729237 (View on PubMed)

Other Identifiers

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IRB-15-6639

Identifier Type: -

Identifier Source: org_study_id