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NCT Number: NCT07691996

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

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.

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Key information

Conditions

Critical Illness Disease Attributes ICU ICU Hospitalization Melatonin Pathologic Processes Pathological Conditions, Signs and Symptoms Sleep

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Melatonin

Drug

patients in this arm will recieve melatonin

Primary outcomes

  1. 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

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

  2. , 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

    These measures are obtained from the sleep profiler.

  3. , Delta to Theta ratio

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

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

  4. , Arousal Index

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jag Sunderram, MD

CONTACT

[email protected]

732-235-7038

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 9, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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