RecruitingPhase 2ACTRN12624000991516

SLeep Evaluation and Effectiveness Protocol for Intensive Care Units (SLEEP-ICU)

A randomised, placebo controlled clinical trial of the efficacy of dexmedetomidine as part of a sleep promotion bundle on sleep quality in adults in intensive care who report a subjective sleep disturbance


Sponsor

South Metropolitan Health Service

Enrollment

100 participants

Start Date

Feb 4, 2025

Study Type

Interventional

Conditions

Summary

Incorporating dexmedetomidine into a comprehensive sleep promotion bundle, which includes minimising night-time disruptions and aligning care activities with the patient’s natural sleep-wake cycles, optimising the sleep environment through monitoring temperature, noise and ambient light could significantly enhance sleep quality in ICU patients. Improved sleep may contribute to better recovery outcomes, reduction in delirium incidence, and overall improved patient well-being. The primary objective of this trial is to provide a comprehensive evaluation of the efficacy and safety of dexmedetomidine in improving sleep in adult ICU patients as part of a sleep promotion bundle as determined by the patient’s subjective sleep assessment.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Sleep is critically important to recovery, yet patients in intensive care units (ICUs) are notoriously poor sleepers — lights, noise, around-the-clock nursing care, and medical interventions all disrupt the sleep-wake cycle. Poor sleep in ICU is linked to delirium, slower recovery, and reduced wellbeing. The SLEEP-ICU trial is testing whether a comprehensive 'sleep promotion bundle' — combining the medication dexmedetomidine with environmental improvements like reduced night-time noise and light — can meaningfully improve sleep quality for ICU patients. Participants will be randomly assigned to receive either the full sleep promotion bundle (including dexmedetomidine) or a standard approach. The main outcome is the patient's own rating of their sleep quality, which makes this study particularly patient-centred. You may be eligible if you are an adult aged 18 or older who is currently admitted to an ICU, expected to stay overnight, have no altered mental state that would prevent you from reporting on your sleep, and have already reported poor sleep quality during your ICU stay. Patients with a known allergy to dexmedetomidine, a slow heart rate, or who are pregnant or breastfeeding are not eligible. The study is run by South Metropolitan Health Service.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Dexmedetomidine Description: A once only intravenous administration of dexmedetomidine as part of a sleep promotion bundle. Dose: Variable titration per patient based on clinical response, starting

Dexmedetomidine Description: A once only intravenous administration of dexmedetomidine as part of a sleep promotion bundle. Dose: Variable titration per patient based on clinical response, starting at 0.1 and up to 0.7 mcg/kg/hour. Duration of administration: 8 hours from 22:00 to 06:00 the next morning Mode of administration: Continuous intravenous infusion. Sleep Promotion Bundle Description: A 'Sleep Promotion Bundle Checklist' will be provided to the bedside nurse to address to all the items in the sleep promotion bundle which include: Environmental Modifications/Monitoring Setup of sleep environment monitor by bedside to assess environmental conditions including ambient light (measured in lux), temperature (in degrees Celsius) and noise (in decibels) which will be recorded minutely throughout the 8-hour intervention period (2200-0600hrs). Lighting Adjustments (<50lux) adjusting lights in the patient’s room and surroundings to aim for <50 lux according to ambient light instrument during 8-hour intervention period (2200-0600hrs) offering an eye mask for the patient if appropriate Noise Reduction (<50dB) Aim to keep noise below 50db according to decibel reader instrument Minimizing equipment volume and alarms Encouraging staff to speak softly and close doors quietly Offering earplugs for the patient Temperature Control (20-22 C) Ensuring room temperature is at recommended temperature range according to temperature monitoring device (20-22 degrees Celsius) Providing fans or cooling blankets if the patient is too warm Offering warming blankets to maintain the appropriate temperature Comfort and Positioning The goal is to ensure patient comfort. Nurses will adjust pillows and bedding to achieve the most comfortable position for the patient as subjectively reported by patient. There is no specific guideline for proper positioning, and this may vary based on individual needs and clinical judgment or requirement. Cluster Care Activities Clustering necessary care activities to minimise disturbances Scheduling medications, vital sign checks, and other care tasks to allow uninterrupted sleep periods Pain Management Assessing and managing the patient’s pain effectively Strategies used to manage adherence to the interventions: Monitoring electronic medical records, nursing checklist, staff training and direct supervision from senior nursing.


Locations(3)

Fiona Stanley Hospital - Murdoch

WA, Australia

Sir Charles Gairdner Hospital - Nedlands

WA, Australia

St John of God Hospital, Subiaco - Subiaco

WA, Australia

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ACTRN12624000991516


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