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ICU sleep fix? pink noise and quiet time put to the test

NCT ID NCT07412964

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests two simple, drug-free ways to improve sleep for adults in the intensive care unit: playing pink-brown noise to mask hospital sounds, or a quiet time protocol with earplugs and eye masks. Researchers will track sleep using a wrist-worn smartwatch in 18 patients. The goal is to see if these low-cost approaches can help ICU patients get better rest and support recovery.

What this could mean

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

Active substance
pink-brown noise masking and quiet time protocol (behavioural interventions)
What this could lead to
If it works, this could point toward simple, drug-free ways to help ICU patients sleep better and recover faster.
What could go wrong
This is a very small, early trial with only 18 participants, so results may not apply to all ICU patients. The interventions are non-invasive but may not improve sleep 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

About 18 people

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

Expected to start

May 2026

An estimate. Start dates often move.

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

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: * Inclusion Criteria: * Adults aged 18 years and older * Patients admitted to the adult intensive care unit * Expected ICU stay of at least one night * Ability to tolerate non-invasive sleep-related interventions (earplugs, eye mask, or acoustic masking) * Informed consent obtained from the patient or legally authorized representative Exclusion Criteria: Exclusion Criteria: * Severe hearing impairment preventing use of acoustic interventions * Severe cognitive impairment or coma preventing sleep assessment * Use of continuous deep sedation * Diagnosed sleep disorders requiring pharmacological treatment * Skin conditions preventing use of wrist-worn actigraphy

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Conditions

The condition(s) this trial relates to.

Parasomnias sleep disorder

As listed by the trial registrant

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

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

  • Bolu Izzet Baysal State Hospital

    Bolu, Bolu, 14100, Turkey (Türkiye)

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