Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000991516p
Ethics application status
Submitted, not yet approved
Date submitted
30/07/2024
Date registered
13/08/2024
Date last updated
13/08/2024
Date data sharing statement initially provided
13/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
SLeep Evaluation and Effectiveness Protocol for Intensive Care Units (SLEEP-ICU)
Scientific title
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
Secondary ID [1] 312651 0
nil known
Universal Trial Number (UTN)
U1111-1309-6642
Trial acronym
SLEEP-ICU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep deprivation 334616 0
Delirium 334617 0
Condition category
Condition code
Neurological 331202 331202 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 0.2 and up to 0.7 mcg/kg/hour.
Duration of administration: 9 hours from 21:00 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:

1. 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 9-hour intervention period (2100-0600hrs).

Lighting Adjustments (<10lux)
adjusting lights in the patient’s room and surroundings to aim for <10 lux according to ambient light instrument during 9-hour intervention period (2100-0600hrs)
offering an eye mask for the patient if appropriate

Noise Reduction (<40dB)
Aim to keep noise below 40db according to decibel reader instrument
Minimising 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.


2. Scheduling and Routine

Nighttime Routine
Offering warm drinks (if allowed) and assisted with hygiene needs before sleep
Limiting non-essential care and procedures during nighttime hours

Cluster Care Activities
Clustering necessary care activities to minimise disturbances
Scheduling medications, vital sign checks, and other care tasks to allow uninterrupted sleep periods

3. Medications and Interventions

Review Medications
Reviewing the appropriateness of any overnight medications that may disrupt sleep

Pain Management
Assessing and managing the patient’s pain effectively

4. Patient-Centered Care

Sleep Assessments
Conducting baseline sleep assessment to understand the patient’s specific needs and preferences using provided sleep questionnaire

Patient Education
Nurses and research staff will provide education to the patient and their family about the importance of sleep and ways to promote it through the patient information and consent form discussion. The content and duration of this education can be customised based on the patient’s condition and preferences.

5. Additional Considerations

Cultural and Individual Preferences
The bundle acknowledges and respects the patient’s cultural and personal preferences. Staff will incorporate these preferences into sleep hygiene practices. For example, considering cultural norms related to bedtime routines or personal preferences for sleep environment. This will be asked as a question from bedside nurse or research staff and acted on as deemed appropriate by bedside nurse.

Family Involvement
Family members may be actively involved in establishing a calming bedtime routine if available. This may include providing emotional support, assisting with comfort measures, and promoting a soothing environment. This can be organised and as deemed appropriate by bedside nurse.


Strategies used to manage adherence to the interventions:
Monitoring electronic medical records, nursing checklist, staff training and direct supervision from senior nursing.


Intervention code [1] 329170 0
Treatment: Drugs
Intervention code [2] 329171 0
Prevention
Comparator / control treatment
Placebo: Intravenous infusion of 0.9% normal saline for 9 hours at 5ml/hr
Those receiving this placebo treatment will also receive the same aspects of the sleep promotion bundle as dexmedetomidine group.
Control group
Placebo

Outcomes
Primary outcome [1] 338973 0
Change in sleep quality
Timepoint [1] 338973 0
Prior to 2100hrs (when intervention due to start) and after 0600hrs (after intervention has finished)
Secondary outcome [1] 438130 0
ICU length of stay
Timepoint [1] 438130 0
From time and date of ICU admission to time and date of ICU discharge
Secondary outcome [2] 438131 0
ICU mortality
Timepoint [2] 438131 0
From date and time of randomisation to date and time of death in ICU
Secondary outcome [3] 438132 0
Pharmacological interventions for delirium received during ICU admission.
Timepoint [3] 438132 0
From enrollment to ICU discharge
Secondary outcome [4] 438133 0
Incidence of Delirium at Day 1
Timepoint [4] 438133 0
two assessments, one at enrollment (baseline) and one post intervention up until the end of day 1 of receiving study intervention (eg. intervention runs 2100 to 0600hrs, CAM-ICU would need to be completed after 0600 and by midnight of that day).
Secondary outcome [5] 438134 0
Study drug infusion cessation due to possible adverse events including hypotension and bradycardia
Timepoint [5] 438134 0
During study intervention period
Secondary outcome [6] 438135 0
Number of hours study drug received during intervention period (2100-0600)
Timepoint [6] 438135 0
during study intervention period
Secondary outcome [7] 438286 0
Hospital length of stay
Timepoint [7] 438286 0
From time and date of hospital admission to time and date of hospital discharge
Secondary outcome [8] 438287 0
Hospital mortality
Timepoint [8] 438287 0
From date and time of randomisation to date and time of death in hospital

Eligibility
Key inclusion criteria
1. Adult patient aged 18 years or older admitted to the ICU
2. Expected to remain in the ICU overnight from the time of enrollment.
3. Capacity to complete a self-reported sleep assessment*
4. Subjectively reported sleep disturbance during the current ICU admission**
* Absence of altered mental state and ability to understand sleep questions and provide responses
** According to patient-reported survey (Richards-Campbell Sleep Questionnaire)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Contraindication to dexmedetomidine (including but not limited to allergy and bradycardia)
2. Currently receiving dexmedetomidine
3. Treating clinician believes study participation is not in the patient’s best interest
4. Pregnancy or breastfeeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
1/10/2025
Actual
Date of last data collection
Anticipated
1/11/2025
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 26886 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 42948 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 317082 0
Hospital
Name [1] 317082 0
Fiona Stanley Hospital
Country [1] 317082 0
Australia
Primary sponsor type
Government body
Name
South Metropolitan Health Service
Address
Country
Australia
Secondary sponsor category [1] 319339 0
Hospital
Name [1] 319339 0
Fiona Stanley Hospital
Address [1] 319339 0
Country [1] 319339 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315834 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 315834 0
Ethics committee country [1] 315834 0
Australia
Date submitted for ethics approval [1] 315834 0
31/07/2024
Approval date [1] 315834 0
Ethics approval number [1] 315834 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135946 0
Mr Nicholas Anthony
Address 135946 0
Intensive Care Unit, Fiona Stanley Hospital 11 Robin Warren Drive, Murdoch Western Australia 6150
Country 135946 0
Australia
Phone 135946 0
+61 861526545
Fax 135946 0
Email 135946 0
[email protected]
Contact person for public queries
Name 135947 0
Nicholas Anthony
Address 135947 0
Intensive Care Unit, Fiona Stanley Hospital 11 Robin Warren Drive, Murdoch Western Australia 6150
Country 135947 0
Australia
Phone 135947 0
+61 861526545
Fax 135947 0
Email 135947 0
[email protected]
Contact person for scientific queries
Name 135948 0
Nicholas Anthony
Address 135948 0
Intensive Care Unit, Fiona Stanley Hospital 11 Robin Warren Drive, Murdoch Western Australia 6150
Country 135948 0
Australia
Phone 135948 0
+61 861526545
Fax 135948 0
Email 135948 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
undecided


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.