Melatonin and Sleep in Preventing Delirium in the Hospital

Phase 1

Completed

• Conditions: Delirium
• Interventions: Other: Placebo; Dietary Supplement: Melatonin

• Registration Number: NCT02597231
• Lead Sponsor: Scripps Health

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 Description

Not available

Study Timeline

• Study First Submitted: 2015-10-01
• Study Start: 2015-11
• Study First Submitted QC: 2015-11-03
• Study First Posted: 2015-11-05
• Primary Completion: 2016-12
• Study Completion: 2016-12-31
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-03
• Last Update Posted: 2017-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	Patient in this group will receive a matching placebo pill orally at 9pm.
Melatonin Group	Melatonin	Patients in this group will receive melatonin 3mg orally at 9pm.

Primary Outcome Measures

Name	Time	Method
Delirium as measured by CAM Assessment	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 Outcome Measures

Name	Time	Method
Subjective sleep quality, measured by Richards-Campbell sleep questionnaire	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.
Objective sleep quality, measured by number of nighttime wakenings	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 nocturnal sleep duration	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 sleep latency	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.

Trial Locations

Locations (1)

Scripps Green Hospital; 🇺🇸 La Jolla, California, United States