Melatonin and Sleep in Preventing Delirium in the Hospital

Study Overview
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Brief Summary
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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).

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

Conditions
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Delirium

Intervention / Treatment
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* Dietary Supplement: Melatonin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium, Melatonin