MedTrace Logo

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

NCT07801092 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-09-03

No results posted yet for this study

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

Interventions

OTHER

Triple Sleep-Promotion Protocol

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.

Sponsors & Collaborators

  • Naile ALANKAYA

    lead OTHER

Principal Investigators

  • Naile Alankaya · Çanakkale Onsekiz Mart University, Faculty of Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-15
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07801092 on ClinicalTrials.gov