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Could protecting nighttime sleep in the ICU ward off delirium?

NCT ID NCT07801092

Prevention Sponsor: Naile ALANKAYA Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 03, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This trial tests whether a nighttime care routine called the Triple Sleep-Promotion Protocol can lower the chance of delirium in adults staying in intensive care units (ICUs). Delirium, a state of sudden confusion, is common in ICUs and may be linked to broken sleep and frequent nighttime disturbances. The protocol groups nursing tasks into set windows, offers eye masks and earplugs during protected sleep periods, and cuts down avoidable light and noise. Researchers will randomly assign 200 ICU patients without delirium to receive either this protocol or usual care, then track new delirium cases and sleep quality over up to five days.

What this could mean

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

Active substance
Triple Sleep-Promotion Protocol, a non-pharmacological nursing intervention that clusters nighttime care, provides eye masks and earplugs, and reduces light and noise to protect sleep.
What this could lead to
If effective, this simple, drug-free protocol could offer a practical way to lower delirium risk in intensive care units, potentially improving recovery and shortening hospital stays.
What could go wrong
The trial is relatively small and tests a behavioral intervention, so results may vary across ICUs. Delirium has many causes, and sleep promotion alone may not prevent it in all patients.

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 200 people

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

Started

Aug 2026

Expected to finish

Mar 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: * Age 18 years or older. * Admitted to one of the participating intensive care units. * Expected ICU stay of at least 24 hours. * Richmond Agitation-Sedation Scale (RASS) score between -3 and +4 at baseline. * Negative Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) assessment at baseline. * Able to communicate in Turkish when communication is required for study assessments. * Written informed consent provided by the patient or, when the patient is unable to provide consent because of their clinical condition, by a first-degree relative. Exclusion Criteria: * Positive CAM-ICU assessment at baseline. * Dementia or a severe neurological disorder that may interfere with delirium assessment, including stroke or severe head trauma. * Delirium related to alcohol or substance withdrawal. * Visual or hearing impairment that prevents implementation of the sleep-promotion intervention. * Ear infection or tympanic membrane perforation that precludes the use of earplugs. * Terminal clinical condition.

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Conditions

The condition(s) this trial relates to.

Confusion delirium

As listed by the trial registrant

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

Delirium confusional state

How to take part

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  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

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Contacts and locations

Locations

  • Çanakkale Onsekiz Mart University, Faculty of Health Sciences

    RECRUITING

    Çanakkale, Çanakkale, 17100, Turkey (Türkiye)

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