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Simple sleep cap may improve rest for NICU infants

NCT ID NCT07423962

Symptom relief Sponsor: Aydin Adnan Menderes University Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a specially designed sleep cap could help infants in the neonatal intensive care unit (NICU) sleep longer and stay more stable. Fifty-three newborns over 32 weeks gestation wore the cap from 7 PM to 7 AM for three days while their sleep, heart rate, breathing, oxygen levels, and temperature were monitored. The goal was to see if this simple, non-drug approach could improve sleep and physiological stability in a hospital setting.

What this could mean

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

Active substance
sleep cap
What this could lead to
If it works, this could offer a simple, drug-free way to help NICU babies sleep better and improve their vital signs.
What could go wrong
This is a small, early study with only 53 infants. The cap may not make a big difference, and results might not apply to all NICU babies.

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

53 people

The number who actually took part.

Started

Sep 2020

Finished

Mar 2021

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

32 to 42 weeks

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Newborns who are over 32 weeks gestation and are hospitalized in the NICU * Newborns stable in room air conditions Exclusion Criteria: * Premature infants birth under 32 weeks * Newborns receiving phototherapy treatment * Newborns receiving respiratory support * Newborns with congenital anomalies * Newborns receiving medication that affects sleep (such as caffeine) * Newborns with sepsis * Newborns with congenital diseases * Newborns with diseases affecting the central nervous system

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Conditions

The condition(s) this trial relates to.

sleep disorder

As listed by the trial registrant

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

Neonatal care Neonatal intensive care Neonatal intensive care unit Newborn Nursing care Physiological parameters Sleep

Contacts and locations

Locations

  • Aydın Adnan Menderes University, Faculty of Nursing, Department of Child Health and Disease Nursing

    Aydin, Efeler, Turkey (Türkiye)

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