Not Yet RecruitingPhase 4

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

30 participantsStarted 2026-09-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

, Total sleep time in hours and minutes

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

, Delta to Theta ratio

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

, Arousal Index

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

Trial details

NCT IDNCT07691996

SponsorRutgers, The State University of New Jersey

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

Jag Sunderram, MD

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

View on ClinicalTrials.gov More Critical Illness trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

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

, Total sleep time in hours and minutes

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

, Delta to Theta ratio

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

, Arousal Index

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