Delirium
Conditions
Keywords
Delirium, Melatonin
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).
Interventions
DIETARY_SUPPLEMENTMelatonin
Melatonin is the dietary supplement we are using in delirium prevention.
OTHERPlacebo
Patients in this group will receive a matching placebo pill.
Sponsors
Scripps Clinic
Scripps Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subjective sleep quality following hospital discharge. | 6 months following hospital discharge | Patients will be given an insomnia questionnaire over the phone at 6 months. |
| Disposition following hospitalization | 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. |
| Mortality | 6 month | — |
Countries
United States
Outcome results
None listed