Effects of Melatonin on Sleep Architecture of Critically Ill Patients in the ICU

Phase 4Not Yet RecruitingNCT07691996

Rutgers, The State University of New Jersey30 enrolled

Overview

This is a pilot study to examine the effects of melatonin on the sleep patterns of critically ill patients. Patients will have their sleep patterns measured with a device attached to their head with a headband then be given a dose of melatonin. Their participation in the study will last two days.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Critical Illness ICU ICU Hospitalization Melatonin Sleep

Interventions

MelatoninDRUG

patients in this arm will recieve melatonin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years or older, admitted to the ICU * Expected length of stay of at least 48 hours * Not mechanically ventilated * Able to take oral medications. * Hemodynamically stable as determined by the treating ICU physician * Able to provide informed consent or have consent provided by a legally -authorized representative. Exclusion Criteria: * Mechanically ventilated * Currently using melatonin prior to ICU admission, * Have neurological conditions that may significantly alter sleep architecture, such as traumatic brain injury, stroke, or severe dementia. * Pregnant or lactating individuals * Those individuals with a comfort measures-only status

Outcomes

Primary Outcomes

Sleep Efficiency as measured by total sleep time over time in bed

These measures are obtained from the sleep profiler. Higher sleep efficiency is better.

Time frame: From enrollment to the end of 48 hours of the last subject's participation in the study

, Total sleep time in hours and minutes

These measures are obtained from the sleep profiler.

Time frame: From enrollment to the end of 48 hours of the last subject's participation in the study

, Delta to Theta ratio

These measures are obtained from the sleep profiler Higher delta to Theta ratio is better

Time frame: From enrollment to the end of 48 hours of the last subject's participation in the study

, Arousal Index

These measures are obtained from the sleep profiler. Lower arousal index is better

Time frame: From enrollment to the end of 48 hours of the last subject's participation in the study

Central Contacts

Jag Sunderram, MD

CONTACT

732-235-7038 sunderja@rwjms.rutgers.edu

Data from ClinicalTrials.gov

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