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

NCT07801092 | Recruiting

• 1 other identifier: COMU-SBF-NA-05
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Delirium Confusional State

Keywords

Intensive Care Unit; Sleep Promotion; Delirium Prevention; Nursing Intervention

Outcome Measures

Primary Outcomes (1)

• Incidence of New-Onset Delirium

  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.

  Up to 5 days after randomization

Secondary Outcomes (1)

• Subjective Sleep Quality Assessed by the Richards-Campbell Sleep Questionnaire

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

Study Arms (2)

Usual ICU Care

NO INTERVENTION

Participants assigned to this arm receive usual ICU care according to the routine practices of the participating ICU. No study-specific nighttime care clustering, eye mask, earplugs, or structured reduction of nighttime light and noise is provided as part of the study. All routine clinical monitoring, nursing care, and medically necessary procedures continue according to standard ICU practice.

Triple Sleep-Promotion Protocol

EXPERIMENTAL

Participants assigned to this arm receive the Triple Sleep-Promotion Protocol in addition to usual ICU care. The protocol includes clustering nighttime nursing care, offering an eye mask and earplugs during designated protected sleep periods, and reducing avoidable nighttime light and noise whenever clinically feasible. The intervention is implemented during the nighttime period, approximately 22:00-08:00. Urgent or clinically necessary care, monitoring, and patient safety requirements take priority over all sleep-promotion procedures.

Other: Triple Sleep-Promotion Protocol

Interventions

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.

Triple Sleep-Promotion Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Naile ALANKAYA: lead

Study Sites (1)

Çanakkale Onsekiz Mart University, Faculty of Health Sciences

Çanakkale, Çanakkale, 17100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Confusion

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Naile Alankaya

  Çanakkale Onsekiz Mart University, Faculty of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naile Alankaya, Assosiate Prof. PhD

CONTACT

+905334256510; naile.alankaya@gmail.com

Sevda Ateş

CONTACT

naile.alankaya@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention, participants, care providers, investigators, and outcome assessors are not masked to group allocation. However, the statistician performing the primary analyses will be blinded to treatment allocation. The groups will be provided using coded labels, and treatment identity will not be disclosed until the prespecified primary analyses have been completed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants are individually randomized in a 1:1 ratio to either the Triple Sleep-Promotion Protocol plus usual ICU care or usual ICU care alone. Randomization is stratified by study center using variable block sizes of 4 and 6.

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 3, 2026
• Study Start: August 15, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)