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NCT Number: NCT07801092

Triple Sleep-Promotion Protocol for Delirium Prevention in Intensive Care Patients

Delirium is a common complication in intensive care units (ICUs) and may be associated with sleep disruption and frequent nighttime disturbances. This randomized controlled trial will evaluate whether a multicomponent nighttime sleep-promotion intervention, called the Triple Sleep-Promotion Protocol, can reduce the occurrence of new-onset delirium in adult ICU patients.

The study is being conducted in four ICUs in Türkiye. Eligible patients who do not have delirium at the beginning of the study will be randomly assigned to either the intervention group or the control group. The intervention includes clustering nighttime nursing care, offering an eye mask and earplugs during protected sleep periods, and reducing avoidable nighttime light and noise whenever clinically feasible. Patients in the control group will receive usual ICU care. Patient safety and clinically necessary care will take priority over all sleep-promotion procedures.

Participants will be followed during their ICU stay for up to five days. Delirium will be assessed twice daily using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Nighttime sleep quality will also be assessed each morning using the Richards-Campbell Sleep Questionnaire. The primary aim is to determine whether the Triple Sleep-Promotion Protocol reduces the incidence of new-onset delirium compared with usual ICU care.

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Key information

Conditions

Delirium Confusional State Confusion Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Çanakkale Onsekiz Mart University, Faculty of Health Sciences

Çanakkale, 17100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ayten Dinç, PhD

CONTACT

[email protected]

About this study

Sleep disruption is common among critically ill patients and may contribute to the development of delirium. Nighttime sleep in the ICU can be disrupted by environmental light and noise, frequent nursing activities, monitoring, and other clinically necessary procedures. Non-pharmacological strategies that reduce avoidable nighttime disturbances may therefore represent a feasible approach to supporting sleep and preventing delirium without adding medication-related risks.

The Triple Sleep-Promotion Protocol was developed as a multicomponent nursing intervention integrating clustered nighttime nursing care, protected sleep periods, eye mask and earplug use, and pragmatic reduction of avoidable nighttime light and noise. The protocol is designed to reduce modifiable sleep disturbances while maintaining routine clinical monitoring and prioritizing patient safety and necessary care at all times.

This multicenter randomized controlled trial will examine whether implementation of the Triple Sleep-Promotion Protocol reduces new-onset delirium compared with usual ICU care. The study will also evaluate subjective nighttime sleep quality and document intervention adherence and clinically necessary protocol interruptions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Triple Sleep-Promotion Protocol

Other

The Triple Sleep-Promotion Protocol is a multicomponent, non-pharmacological nighttime nursing intervention implemented approximately between 22:00 and 08:00. Nursing care is clustered within three designated periods (22:00-01:00, 02:30-04:00, and 05:30-07:00) to support two protected sleep periods (01:00-02:30 and 04:00-05:30). During the protected sleep periods, participants are offered an eye mask and earplugs, and avoidable environmental light and noise are reduced whenever clinically feasible. Urgent or clinically necessary nursing care, medical procedures, monitoring, and patient safety requirements take priority over the protocol. If the evening RASS score is -4 or -5, the sleep-promotion intervention is withheld for that night and the participant is reassessed subsequently. The intervention is discontinued after the first positive CAM-ICU assessment.

Primary outcomes

  1. Incidence of New-Onset Delirium

    Time frame: Up to 5 days after randomization

    New-onset delirium is defined as at least one positive Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) assessment during ICU follow-up. Only participants who are CAM-ICU negative at baseline are randomized. Richmond Agitation-Sedation Scale (RASS) is assessed before each CAM-ICU assessment; CAM-ICU is performed when RASS is -3 or higher, while RASS -4 or -5 is recorded as not assessable.

Secondary outcomes

  1. Subjective Sleep Quality Assessed by the Richards-Campbell Sleep Questionnaire

    Time frame: Daily during ICU follow-up, up to 5 days after randomization

    Subjective sleep quality is assessed using the Richards-Campbell Sleep Questionnaire (RCSQ), a five-item instrument evaluating the preceding night's sleep. Each item is scored from 0 to 100, and the mean of the five items is calculated as the overall RCSQ score (range: 0-100). Higher scores indicate better perceived sleep quality. The RCSQ is administered each morning between 07:00 and 08:00 during ICU follow-up. Assessments are discontinued after the first positive CAM-ICU assessment.

Study contacts

Contact information is provided by the study sponsor or research team.

Naile Alankaya, Assosiate Prof. PhD

CONTACT

[email protected]

+905334256510

Sevda Ateş

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Naile ALANKAYA

Other

Registry information

Official study title

Effect of a Triple Sleep-Promotion Protocol on Delirium Incidence in Intensive Care Units: A Multicenter Stratified Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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