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Not yet recruiting NCT07691996

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

Phase IV Interventional Critical Illness ICU ICU Hospitalization Melatonin

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Melatonin.
Who it may be relevant to
Registry conditions: Critical Illness, ICU, ICU Hospitalization, Melatonin. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Interventions

  • Drug Melatonin
    patients in this arm will recieve melatonin

Primary outcome measures

  • Sleep Efficiency as measured by total sleep time over time in bed [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 [Time frame: From enrollment to the end of 48 hours of the last subject's participation in the study]
  • , Delta to Theta ratio [Time frame: From enrollment to the end of 48 hours of the last subject's participation in the study]
  • , Arousal Index [Time frame: From enrollment to the end of 48 hours of the last subject's participation in the study]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07691996 · Pro2025002445

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗