Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000991516
Ethics application status
Approved
Date submitted
30/07/2024
Date registered
13/08/2024
Date last updated
27/04/2025
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 0.1 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.


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 8 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
The primary outcome is difference in mean ‘Sleep Quality’ scores of the RichardsCampbell Sleep Questionnaire (RCSQ) [Appendix 1] between the dexmedetomidine and placebo groups post-intervention.
Timepoint [1] 338973 0
Post intervention (up to 12 hours post completion of intervention period)
Secondary outcome [1] 438130 0
ICU length of stay
Timepoint [1] 438130 0
From time and date of randomisation 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
Post randomisation 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 up to day 7 post randomisation
Timepoint [4] 438133 0
any positive CAM-ICU assessments post randomisation up until the end of day 7
Secondary outcome [5] 438286 0
Hospital length of stay
Timepoint [5] 438286 0
From time and date of randomisation to time and date of hospital discharge
Secondary outcome [6] 438287 0
Hospital mortality
Timepoint [6] 438287 0
From date and time of randomisation to date and time of death in hospital
Secondary outcome [7] 446861 0
Richards-Campbell Sleep Questionnaire (RCSQ) score at day 30 post randomisation
Timepoint [7] 446861 0
day 30 post randomisation
Secondary outcome [8] 446862 0
Difference in mean ‘Sleep Depth’ scores of the Richards-Campbell Sleep Questionnaire (RCSQ) between the dexmedetomidine and placebo groups post-intervention
Timepoint [8] 446862 0
Post intervention (up to 12 hours post completion of intervention period)
Secondary outcome [9] 446863 0
Difference in mean ‘Sleep Latency’ scores of the Richards-Campbell Sleep Questionnaire (RCSQ) between the dexmedetomidine and placebo groups post-intervention
Timepoint [9] 446863 0
Post intervention (up to 12 hours post completion of intervention period)
Secondary outcome [10] 446864 0
Difference in mean ‘Frequency of Awakenings’ scores of the RCSQ between the dexmedetomidine and placebo groups post-intervention
Timepoint [10] 446864 0
Post intervention (up to 12 hours post completion of intervention period)
Secondary outcome [11] 446865 0
Difference in mean ‘Return to Sleep’ scores of the RCSQ between the dexmedetomidine and placebo groups post-intervention
Timepoint [11] 446865 0
Post intervention (up to 12 hours post completion of intervention period)
Secondary outcome [12] 446866 0
EQ5D5L at day 30 post randomisation
Timepoint [12] 446866 0
day 30 post randomisation

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 Richard Campbells Sleep Questionnaire ‘Sleep Quality’ score of
<50
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 an alpha-2 agonist
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 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The sample size calculation was based on detecting differences in mean RCSQ
‘Sleep Quality’ scores between the dexmedetomidine and placebo groups. The key
parameters used in this calculation included a significance level (a) of 0.05, a power
(1-ß) of 0.80, the expected difference in mean RCSQ scores between the two
groups, and the standard deviation (s) of the RCSQ scores. For this study, we used
data from a recent quality improvement project in the FSH ICU with a sample of 30
patients who met inclusion criteria matched to this study and completed an RCSQ.
The mean sleep quality score was 37.0 (s = 32.9). To have a meaningful
improvement in sleep and a sleep quality score >50, we assumed an expected
difference in mean RCSQ scores of 20 points and a standard deviation of 32.9
points. Using the Z-tests for significance level and power, the calculation indicated
that approximately 42 participants per group are required to achieve 80% power with
a significance level of 0.05. To account for an expected dropout rate of 20%, the
adjusted sample size is 50 participants per group, resulting in a total of 100
participants needed for the study

All analyses will be conducted on an intention-to-treat basis. No imputation will be
made for missing data. The primary outcome will be analysed using independent
samples t-test or Wilcoxon rank-sum (if non-normal distribution) to determine a
statistically significant difference in mean sleep quality scores between intervention
groups (significance level (a) of 0.05). A sensitivity analysis will be conducted to
assess the robustness of the primary analysis using multivariable analysis adjusting
for baseline factors. Secondary outcomes will be reported as number (%), mean (+-
SD) or median (IQR) with between-group differences analysed using Chi2, students
t-test or the Wilcoxon rank-sum test as appropriate.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2024
Actual
4/02/2025
Date of last participant enrolment
Anticipated
1/01/2026
Actual
Date of last data collection
Anticipated
31/01/2026
Actual
Sample size
Target
100
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 26886 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 27840 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [3] 27841 0
St John of God Hospital, Subiaco - Subiaco
Recruitment postcode(s) [1] 42948 0
6150 - Murdoch
Recruitment postcode(s) [2] 44035 0
6009 - Nedlands
Recruitment postcode(s) [3] 44036 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 317082 0
Hospital
Name [1] 317082 0
Fiona Stanley Hospital
Country [1] 317082 0
Australia
Funding source category [2] 318819 0
Charities/Societies/Foundations
Name [2] 318819 0
Western Australian Nurses Memorial Charity Trust
Country [2] 318819 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
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
10/09/2024
Ethics approval number [1] 315834 0
RGS0000007144

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 the study consider sharing individual participant data?
No
No 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.