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PICU sleep study aims to reset Kids' body clocks with light and meals

NCT ID NCT06505447

Knowledge-focused Sponsor: State University of New York at Buffalo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether it is possible to measure and improve sleep and body clock rhythms in children aged 3 to 6 who are in the pediatric intensive care unit (PICU). Researchers will use a watch-like device and saliva tests to track sleep, and try two simple approaches: bright light therapy during the day and limiting food to daytime hours. The goal is to see if these methods are practical, not yet to prove they improve health.

What this could mean

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

Active substance
Light therapy and daytime restricted feeding
What this could lead to
If successful, this could lead to better ways to support sleep and recovery for children in intensive care.
What could go wrong
This is a very small, early feasibility study with only 30 children. It is not designed to prove any health benefits, only whether the approach is practical.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

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

Started

Dec 2024

Expected to finish

Jan 2027

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

3 to 6 years

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: 1. Child age 3 to 6 years old on the day of PICU admission 2. English-speaking parent at the bedside 3. Child expected to remain in the PICU over 24 to 48 hours Exclusion Criteria: 1. Child is in end-of-life care 2. The child is receiving neuromuscular blockade for any reason 3. Caregiver or parent not at the bedside

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Conditions

The condition(s) this trial relates to.

circadian rhythm sleep disorder Critical Illness Parasomnias sleep disorder

As listed by the trial registrant

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

Children, only Circadian dysrhythmia Critical illness Sleep disturbance

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • John R. Oishei Children's Hospital

    RECRUITING

    Buffalo, New York, 14203, United States

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