Clinical Trial: Melatonin and Sleep in Preventing Delirium in the Hospital

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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).

Detailed Summary:
Sponsor: Scripps Health

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.
  • 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.
  • 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.


Original Secondary Outcome: Same as current

Information By: Scripps Health

Dates:
Date Received: October 1, 2015
Date Started: November 2015
Date Completion: October 2016
Last Updated: November 3, 2015
Last Verified: October 2015