Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000688088
Ethics application status
Approved
Date submitted
18/08/2010
Date registered
20/08/2010
Date last updated
21/06/2021
Date data sharing statement initially provided
21/06/2021
Date results provided
21/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving sleep for the intensive care patient
Scientific title
A preintervention-postintervention study investigating the effect of a rest and sleep guideline on the amount and quality of sleep in intensive care patients
Secondary ID [1] 252502 0
none
Universal Trial Number (UTN)
Trial acronym
ICU sleep study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The amount and quality of sleep 257988 0
Condition category
Condition code
Public Health 258154 258154 0 0
Epidemiology
Other 258183 258183 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The implementation of a 'rest and sleep guideline' using interventions suggested by the entire healthcare team including: a daytime rest period (in the afternoon for 1.5 hours instigated by bedside nurses), ear plugs, eye masks, clustered care and noise reduction. The guideline has been implemented using a multifaceted approach (e.g. group sessions, one to one academic detailing, auditing with feedback in the intensive care unit (ICU) newsletter, e mail and posters) and designed to be sustained over the long-term (until further evidence becomes available to improve sleep further).
Intervention code [1] 257039 0
Prevention
Comparator / control treatment
A pre-post design. A group of patients will have their sleep monitored before the introduction of the intervention and another group will have their sleep monitored after the introduction of the guideline.
Control group
Active

Outcomes
Primary outcome [1] 259015 0
Total sleep time
Timepoint [1] 259015 0
A 24 hour sleep period using continuous monitoring
Secondary outcome [1] 265247 0
The number of microarousals defined using the American Academy of Sleep Medicine criteria and assessed by an accredited experienced sleep technologist.
Criteria: ' an abrupt shift in electroencephalograph frequency including alpha, theta and/or frequencies >16Hertz (not spindles) that lasts at least 3 seconds, with at least 10 seconds of stable sleep preceding the change. Scoring of arousal during rapid eye movement (REM) sleep requires a concurrent increase in submental electromyography (EMG) lasting at least 1 second.'
No adverse events are expected.
Timepoint [1] 265247 0
24 hour sleep monitoring
Secondary outcome [2] 265250 0
Quantity (percentage) of each sleep stage (1 to 4 and Rapid Eye Movement)
Timepoint [2] 265250 0
A 24 hour sleep period using continuous monitoring

Eligibility
Key inclusion criteria
Treated in the intensive care unit (ICU) for 24 hours and likely to be in for a further 48 hours
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History/evidence of sleep disorder, central nervous system impairment e.g. confirmed brain injury on Magnetic Resonance Imaging (MRI)/ Computerised Tomography (CT) scan, diagnosis of dementia

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Preintervention-postintervention study design. Thirty intensive care unit (ICU) patients were enrolled in the preintervention phase and had their sleep monitored continuously for one 24 hour period. These patients received standard care. The intervention (a 'rest and sleep guideline') has been implemented. In the postintervention phase another 30 (different) patients will be enrolled and have their sleep monitored continuously for one 24 hour period.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/02/2009
Actual
2/02/2009
Date of last participant enrolment
Anticipated
Actual
3/04/2011
Date of last data collection
Anticipated
Actual
4/04/2011
Sample size
Target
57
Accrual to date
Final
57
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 257504 0
Other
Name [1] 257504 0
Australian College of Critical Care Nurses
Country [1] 257504 0
Australia
Funding source category [2] 308911 0
Charities/Societies/Foundations
Name [2] 308911 0
Intensive Care Foundation
Country [2] 308911 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
15 Broadway,
Ultimo, NSW 2007
Country
Australia
Secondary sponsor category [1] 256740 0
Charities/Societies/Foundations
Name [1] 256740 0
Northcare
Address [1] 256740 0
PO Box 3553
Erina
NSW 2250
Country [1] 256740 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259513 0
Harbour Human Research Ethics Comittee of Northern Sydney Central Coast Health
Ethics committee address [1] 259513 0
Ethics committee country [1] 259513 0
Australia
Date submitted for ethics approval [1] 259513 0
18/08/2008
Approval date [1] 259513 0
18/09/2008
Ethics approval number [1] 259513 0
0809-201M (SP)
Ethics committee name [2] 259514 0
UTS Human Research Ethics Committee
Ethics committee address [2] 259514 0
Ethics committee country [2] 259514 0
Australia
Date submitted for ethics approval [2] 259514 0
25/08/2008
Approval date [2] 259514 0
Ethics approval number [2] 259514 0
2008-292-R

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

Contacts
Principal investigator
Name 31535 0
Dr Rosalind Elliott
Address 31535 0
Intensive care unit Level 6, Main Building Royal North Shore Hospital St Leonards NSW 2065
Country 31535 0
Australia
Phone 31535 0
+61 2 9926 4801
Fax 31535 0
Email 31535 0
[email protected],au
Contact person for public queries
Name 14782 0
Rosalind Elliott
Address 14782 0
Intensive care unit
Level 6, Main Building
Royal North Shore Hospital
St Leonards
NSW 2065
Country 14782 0
Australia
Phone 14782 0
++61 2 9926 4801
Fax 14782 0
Email 14782 0
[email protected]
Contact person for scientific queries
Name 5710 0
Rosalind Elliott
Address 5710 0
Intensive care unit
Level 6, Main Building
Royal North Shore Hospital
St Leonards
NSW 2065
Country 5710 0
Australia
Phone 5710 0
+61 411 694 387
Fax 5710 0
Email 5710 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
This was not requested in the original HREC and governance application, therefore approval was not provided.


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
SourceTitleYear of PublicationDOI
EmbaseFactors affecting sleep in the critically ill: an observational study.2014https://dx.doi.org/10.1016/j.jcrc.2014.05.015
N.B. These documents automatically identified may not have been verified by the study sponsor.