Skip to main content
OpenTrials
Completed

NCT Number: NCT02597231

Melatonin and Sleep in Preventing Delirium in the Hospital

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Delirium Confusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Scripps Green Hospital

La Jolla, California, 92037, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

melatonin

Dietary Supplement

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

Placebo

Other

Patients in this group will receive a matching placebo pill.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Other outcomes

  1. Mortality

    Time frame: 6 month

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Scripps Health

Other

Collaborators

  • Scripps Clinic

Registry information

Official study title

Melatonin and Sleep in Preventing Delirium in the Hospital: A Randomized Placebo-controlled Trial

Acronym: MELO

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 5, 2015
Registry last updated
Oct 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.