Melatonin and Sleep in Preventing Delirium in the Hospital

Delirium Clinical Trial

— MELO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02597231
• Other study ID #: IRB-15-6639
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 1, 2015
• Last updated: October 3, 2017
• Start date: November 2015
• Est. completion date: December 31, 2016

Study information

• Verified date: October 2017
• Source: Scripps Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 31, 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium

Intervention

Dietary Supplement:
• Melatonin
Melatonin is the dietary supplement we are using in delirium prevention.

Other:
• Placebo
Patients in this group will receive a matching placebo pill.

Locations

Country	Name	City	State
United States	Scripps Green Hospital	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
Scripps Health	Scripps Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality		6 month
Other	Disposition following hospitalization	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.
Other	Subjective sleep quality following hospital discharge.	Patients will be given an insomnia questionnaire over the phone at 6 months.	6 months following hospital discharge
Primary	Delirium as measured by CAM Assessment	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	Objective Sleep Quality, measured by nocturnal sleep duration	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.
Secondary	Objective sleep quality, measured by number of nighttime wakenings	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.
Secondary	Objective sleep quality, measured by sleep latency	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.
Secondary	Subjective sleep quality, measured by Richards-Campbell sleep questionnaire	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.