Melatonin and Sleep in Preventing Delirium in the Hospital

NCT02597231 | Completed Phase 1

• 1 other identifier: IRB-15-6639
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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).

Conditions

Delirium

Keywords

Delirium; Melatonin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Other Outcomes (3)

• Mortality

  6 month

• Disposition following hospitalization

  1 day following hospital discharge or at the 2 week time end point of the study.

• Subjective sleep quality following hospital discharge.

  6 months following hospital discharge

Study Arms (2)

Melatonin Group

EXPERIMENTAL

Patients in this group will receive melatonin 3mg orally at 9pm.

Dietary Supplement: Melatonin

Placebo Group

PLACEBO COMPARATOR

Patient in this group will receive a matching placebo pill orally at 9pm.

Other: Placebo

Interventions

Melatonin DIETARY_SUPPLEMENT

Melatonin is the dietary supplement we are using in delirium prevention.

Melatonin Group

Placebo OTHER

Patients in this group will receive a matching placebo pill.

Placebo Group

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Scripps Health: lead
• Scripps Clinic: collaborator

Study Sites (1)

Scripps Green Hospital

La Jolla, California, 92037, United States

Location

Related Publications (2)

• 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.

  PMID: 33051948 DERIVED

• 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.

  PMID: 29729237 DERIVED

MeSH Terms

Conditions

Delirium

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Thomas McCarthy, MD

  Scripps Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: November 5, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 31, 2016
• Last Updated: October 4, 2017

Record last verified: 2017-10

Locations

US (1)