Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000742875
Ethics application status
Approved
Date submitted
14/04/2021
Date registered
11/06/2021
Date last updated
8/09/2024
Date data sharing statement initially provided
11/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised control trial investigating the effect of temazepam on sleep in critically ill patients
Scientific title
A pilot, parallel group, blinded, placebo controlled, ranDomised pRagmatic clinical trial investigating the Effect of temazepAM on objective and subjective measures of sleep in critically ill adult patients
(The DREAM trial)
Secondary ID [1] 303952 0
Nil known
Universal Trial Number (UTN)
Trial acronym
DREAM trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep disruption 321547 0
Condition category
Condition code
Neurological 319295 319295 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single dose of Temazepam, administered enterally by the bedside nurse.
Dose administration will be as follows:

For patients aged over 80 years and/or weigh under or equal to 50 kg (actual body weight), 10 mg of temazepam will be administered.

For patients aged less than or equal to 80 years and weighing less than or equal to 100 kg, 20 mg of temazepam will be administered.

For patients aged less than or equal to 80 years and weighing greater than 100 kg, 30 mg of temazepam will be administered.

Adherence to the intervention will be monitored by asking the bedside nurse to place the used syringe in a container provided on the day of the study. Research staff will then check for the empty syringe and fill out the drug reconciliation log accordingly.
Intervention code [1] 320257 0
Treatment: Drugs
Comparator / control treatment
A placebo (10 ml of water in a syringe) will be provided to patients in the control group. Neither the nurse administering the medication nor the patient will be aware of whether temazepam or placebo is given as the study is blinded.
Control group
Placebo

Outcomes
Primary outcome [1] 327175 0
Total sleep duration, in minutes, as measured by the bedside nurse.
Timepoint [1] 327175 0
The 12 hours following the intervention or control administration.
Secondary outcome [1] 394063 0
Richards-Campbell Sleep Questionnaire, a 100-mm visual-analogue scale of perceived patient sleep, completed by the bedside nurse.
Timepoint [1] 394063 0
Morning following administration of temazepam or placebo.
Secondary outcome [2] 394065 0
Total sleep time, measured objectively by polysomnography.
Timepoint [2] 394065 0
12 hours following administration of temazepam or placebo.
Secondary outcome [3] 394067 0
Duration spent in stages of sleep (N1,2,3, and REM sleep), measured objectively by polysomnography.
Timepoint [3] 394067 0
12 hours following administration of temazepam or placebo.
Secondary outcome [4] 394069 0
Sleep latency (i.e. time to sleep), measured objectively by polysomnography.
Timepoint [4] 394069 0
12 hours following administration of temazepam or placebo.
Secondary outcome [5] 394070 0
Duration of unbroken sleep, measured objectively by polysomnography.
Timepoint [5] 394070 0
12 hours following administration of temazepam or placebo.
Secondary outcome [6] 394071 0
Confusion Assessment Method for the ICU (CAM-ICU) status prior to study drug administration and morning after study drug administration.
CAM assessment score completed by bedside nurse twice on the study day.
Timepoint [6] 394071 0
6 hours prior and 6 hours after the administration of temazepam or placebo.

Eligibility
Key inclusion criteria
• Aged >/= 18 years
• The treating clinician considers it highly likely that they would prescribe a pharmacological sleep aid that evening
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• The treating clinician believes that an alternative sedating drug (e.g. quetiapine, melatonin, etc.) is in the best interest of the patient,
• They are pregnant,
• They have a known hypersensitivity to temazepam, and
• Were previously enrolled in this trial.

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)
This will be performed by an unblinded researcher (who will not be involved in data collection and analysis) by central randomisation via a computer, with concealment from investigators via the program REDCap.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated 1:1 schedule by the Stata routine ralloc (Stata version 15.1, College Station, Texas). This will be done using a predetermined seed number, which will be securely stored so that the sequence can be re-generated or extended if necessary.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on mean (SD) of 180 (80) min of sleep in patients receiving usual care (25), we will have 80% power to detect a difference of 60 min with temazepam (20), at a two sided alpha of 0.05, if 56 participants are included.
The statistical focus should be on descriptive statistics (means, proportions, medians) and differences between the groups and their associated confidence intervals or quantile ranges, rather than repeated P value testing, to provide robust estimate of possible treatment effects. Pilot studies may usefully help assess minimum clinically important differences even if confidence intervals reported are numerically less than 95% (such as 85% or 75%) (37). We will however conduct inferential statistical testing using unpaired Student’s t-test for the primary outcome.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
21/10/2020
Date of last participant enrolment
Anticipated
31/12/2022
Actual
9/05/2024
Date of last data collection
Anticipated
27/01/2023
Actual
16/05/2024
Sample size
Target
56
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19099 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 33657 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 308333 0
Hospital
Name [1] 308333 0
Royal Melbourne Hospital
Country [1] 308333 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health
Address
Royal Melbourne Hospital 300 Grattan St, Parkville,3050, VIC
Country
Australia
Secondary sponsor category [1] 309149 0
None
Name [1] 309149 0
Address [1] 309149 0
Country [1] 309149 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308308 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 308308 0
Ethics committee country [1] 308308 0
Australia
Date submitted for ethics approval [1] 308308 0
26/11/2019
Approval date [1] 308308 0
30/03/2020
Ethics approval number [1] 308308 0
HREC/59713/MH-2019

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

Contacts
Principal investigator
Name 110250 0
A/Prof Adam Deane
Address 110250 0
Royal Melbourne Hospital, 300 Grattan St, Parkville, VIC 3050.
Country 110250 0
Australia
Phone 110250 0
+61 3 9342 9254
Fax 110250 0
Email 110250 0
[email protected]
Contact person for public queries
Name 110251 0
Brianna Tascone
Address 110251 0
Royal Melbourne Hospital, 300 Grattan St, Parkville, VIC 3050.
Country 110251 0
Australia
Phone 110251 0
+61 393429252
Fax 110251 0
Email 110251 0
[email protected]
Contact person for scientific queries
Name 110252 0
Brianna Tascone
Address 110252 0
Royal Melbourne Hospital, 300 Grattan St, Parkville, VIC 3050.
Country 110252 0
Australia
Phone 110252 0
+61 393429252
Fax 110252 0
Email 110252 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


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.