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Simple sleep aids tested for kids in intensive care

NCT ID NCT07626047

Symptom relief Sponsor: Burçak Bahadır 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether eye masks and calming audiobooks could improve sleep for children aged 6-15 in the pediatric intensive care unit. Forty-two children were randomly assigned to use these tools or receive standard care. Researchers measured sleep quality and vital signs to see if these simple, non-drug approaches made a difference.

What this could mean

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

Active substance
Eye mask and audiobook through headphones
What this could lead to
If effective, these simple, non-drug methods could become standard care to help children sleep better in the pediatric ICU.
What could go wrong
This is a small, single-center study with only 42 participants. Results may not apply to all children or ICUs, and the interventions may not work for everyone.

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

42 people

The number who actually took part.

Started

Feb 2025

Finished

Dec 2025

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

6 to 15 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: * Being between 6 and 15 years of age * Being hospitalized in the pediatric intensive care unit * Not being intubated * Not being monitored under sedation * Having a Glasgow Coma Scale (GCS) score of 13 or higher * Obtaining written and verbal informed consent from the child and the legal guardian Exclusion Criteria: * Presence of neurological disorders (e.g., cerebral palsy, epilepsy, neuromuscular diseases, mental retardation) * Active central nervous system infection (meningitis, encephalitis) or sepsis * Presence of visual or hearing impairment * Continuous use of medications that may affect sleep patterns (e.g., anticonvulsants, antidepressants, antihistamines) * Administration of sedative medication during the follow-up period * Length of stay in the pediatric intensive care unit being less than three days

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Conditions

The condition(s) this trial relates to.

insomnia Parasomnias sleep disorder

As listed by the trial registrant

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

Healing care environment Pediatric intensive care unit Sleep disturbance Sleep quality

Contacts and locations

Locations

  • Ege University Hospital Pediatric Intensive Care Unit

    Izmir, Bornova, 35080, Turkey (Türkiye)

More trials for these conditions

Other studies related to the condition(s) this trial covers.