Triple sleep-promotion for delirium prevention in ICU patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized controlled trial tests whether a multicomponent nighttime sleep-promotion protocol can lower the incidence of new-onset delirium in adult ICU patients. The protocol includes clustering nighttime nursing care, providing an eye mask and earplugs during protected sleep periods, and reducing avoidable nighttime light and noise when possible, while prioritizing patient safety. Participants will be followed for the duration of their ICU stay to track delirium occurrence, subjective sleep quality, and adherence to the intervention. The study is conducted in four ICUs in Türkiye and compares the intervention against standard ICU care.

Why it matters

Who can join: the full rules

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.

Where it's running

• Çanakkale Onsekiz Mart University, Faculty of Health Sciences
  Çanakkale, Çanakkale, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Naile Alankaya — Çanakkale Onsekiz Mart University, Faculty of Health Sciences
• Study coordinator: Naile Alankaya, Assosiate Prof. PhD
• Email: naile.alankaya@gmail.com
• Phone: +905334256510

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.