Melatonin and Sleep in Preventing Delirium in the Hospital (MELO)

October 3, 2017 updated by: Scripps Health

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Scripps Green Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 100 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Melatonin Group
Patients in this group will receive melatonin 3mg orally at 9pm.
Dietary supplement: Melatonin
Melatonin is the dietary supplement we are using in delirium prevention.
Placebo Comparator: Placebo Group
Patient in this group will receive a matching placebo pill orally at 9pm.
Other: Placebo
Patients in this group will receive a matching placebo pill.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delirium as measured by CAM Assessment
Time Frame: Delirium assessments will be made twice daily (am and pm measurements) throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.
Primary outcome is whether patients become delirious, as measured by CAM during their hospital admission.
Delirium assessments will be made twice daily (am and pm measurements) throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Sleep Quality, measured by nocturnal sleep duration
Time Frame: nightly, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.
Nocturnal sleep duration will be measured by wireless actigraphy.
nightly, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.
Objective sleep quality, measured by number of nighttime wakenings
Time Frame: nightly, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.
We will measure the number of nighttime wakenings using wireless actigraphy.
nightly, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.
Objective sleep quality, measured by sleep latency
Time Frame: nightly, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.
We will measure sleep latency (time to fall asleep) using wireless actigraphy.
nightly, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.
Subjective sleep quality, measured by Richards-Campbell sleep questionnaire
Time Frame: once daily, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.
Patients will be asked to fill out the Richards-Campbell sleep question, which uses a visual analog scale for 5 questions that are designed to assess a patient's perceived sleep quality.
once daily, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 6 month
6 month
Disposition following hospitalization
Time Frame: 1 day following hospital discharge or at the 2 week time end point of the study.
We want to determine if the patient is discharged to home, to a post-acute care facility, or to a new type of living facility that was different from their prior living situation.
1 day following hospital discharge or at the 2 week time end point of the study.
Subjective sleep quality following hospital discharge.
Time Frame: 6 months following hospital discharge
Patients will be given an insomnia questionnaire over the phone at 6 months.
6 months following hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scripps Health

Collaborators

Scripps Clinic

Investigators

  • Principal Investigator: Thomas McCarthy, MD, Scripps Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

October 1, 2015

First Submitted That Met QC Criteria

November 3, 2015

First Posted (Estimate)

November 5, 2015

Study Record Updates

Last Update Posted (Actual)

October 4, 2017

Last Update Submitted That Met QC Criteria

October 3, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-15-6639

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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