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Can melatonin help ICU patients sleep better?

NCT ID NCT07691996

Symptom relief Sponsor: Rutgers, The State University of New Jersey Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Jul 14, 2026 · Updated 3 times

Summary

This pilot study investigates whether melatonin can improve sleep quality in critically ill patients admitted to the ICU. Participants will wear a headband device to measure their sleep patterns and then receive a dose of melatonin. The study lasts two days and aims to see if melatonin can help these patients get more restful sleep.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Melatonin
What this could lead to
If it works, this could point toward a simple, safe way to improve sleep for critically ill patients in the ICU.
What could go wrong
This is a very small pilot study with only 30 participants, so results may not be conclusive or apply to all ICU patients. Melatonin may not significantly improve sleep in this setting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Critical Illness sleep disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Critical illness ICU Icu hospitalization Melatonin Sleep

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

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