Clinical trial NCT02597231: Melatonin and Sleep in Preventing Delirium in the Hospital
Official title: Melatonin and Sleep in Preventing Delirium in the Hospital: A Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Delirium
Keywords: Delirium
Melatonin
Lead sponsor: Scripps Health
Sponsor class: OTHER
Collaborators: name: Scripps Clinic
First posted: 2015-11-05
Enrollment: 94
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: 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

Primary outcomes:
measure: Delirium as measured by CAM Assessment
timeFrame: 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 outcomes:
measure: Objective Sleep Quality, measured by nocturnal sleep duration
timeFrame: nightly, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.
measure: Objective sleep quality, measured by number of nighttime wakenings
timeFrame: nightly, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.
measure: Objective sleep quality, measured by sleep latency
timeFrame: nightly, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.
measure: Subjective sleep quality, measured by Richards-Campbell sleep questionnaire
timeFrame: once daily, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.
Other outcomes:
measure: Mortality
timeFrame: 6 month
measure: Disposition following hospitalization
timeFrame: 1 day following hospital discharge or at the 2 week time end point of the study.
measure: Subjective sleep quality following hospital discharge.
timeFrame: 6 months following hospital discharge
Locations:
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
Study officials:
affiliation: Scripps Health
name: Thomas McCarthy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jaiswal SJ, Kang DY, Wineinger NE, Owens RL. Objectively measured sleep fragmentation is associated with incident delirium in older hospitalized patients: Analysis of data collected from an randomized controlled trial. J Sleep Res. 2021 Jun;30(3):e13205. doi: 10.1111/jsr.13205. Epub 2020 Oct 13.
citation: Jaiswal SJ, McCarthy TJ, Wineinger NE, Kang DY, Song J, Garcia S, van Niekerk CJ, Lu CY, Loeks M, Owens RL. Melatonin and Sleep in Preventing Hospitalized Delirium: A Randomized Clinical Trial. Am J Med. 2018 Sep;131(9):1110-1117.e4. doi: 10.1016/j.amjmed.2018.04.009. Epub 2018 May 3.