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

ConditionDelirium Confusional State

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorNaile ALANKAYA

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Triple Sleep-Promotion Protocol
Other intervention
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.

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: Usual ICU CareNo intervention 0 interventions

Group B: Triple Sleep-Promotion ProtocolExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Up to 5 days after randomization

Secondary outcomes

Subjective Sleep Quality Assessed by the Richards-Campbell Sleep Questionnaire

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.

Time frame

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

Sponsors and contacts

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Naile ALANKAYA

Lead sponsor

Çanakkale Onsekiz Mart University

Sponsor institution

Source ClinicalTrials.gov

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