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Trial registered on ANZCTR


Registration number
ACTRN12619000181101
Ethics application status
Approved
Date submitted
1/02/2019
Date registered
7/02/2019
Date last updated
28/06/2021
Date data sharing statement initially provided
7/02/2019
Date results information initially provided
28/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
An inception cohort study to determine feasibility of measuring sleep, proportion of patients with a new sleep disorder, and sleep changes over time during critical illness and recovery
Scientific title
An inception cohort study to determine feasibility of measuring sleep, proportion of patients with a new sleep disorder, and sleep changes over time during critical illness and recovery
Secondary ID [1] 297270 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 311343 0
Sleep disorder 311372 0
Condition category
Condition code
Neurological 309980 309980 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The following procedures will be carried out by a registered sleep scientist from Royal Melbourne Hospital over three defined study days.

The three study days are as follows:
- one on the RMH ICU (one night after 5 days of ICU admission)
- one on RMH ward (within 3 days of admission to ward)
- one at patient's home 90 days post-hospital discharge.

All objective measures of sleep will be carried out over one night, with the exception of the actigraphy, which will be worn by the participant for up to 7 days prior to third study day.

Actigraphy provides an objective measure of sleep-wake cycles via a non-invasive method attached to the upper limb. This will be used on all three study days.

Portable Polysomnography is used for diagnostic purposes as a measure of assessing sleep disorders at home via electrodes being applied to the patient to assess different sleep parameters. This will be used on the final study day (at participant's home).

Electroencephalogram with Electromyogram and Electrooculogram will be used to assess the electrical activity of the brain, muscle, and the eyes during the sleep-wake cycle. This involves non-invasive placing of electrodes on the scalp and jaw. This will be carried out on the first and second study day.

Subjective assessment will also be carried out by two separate questionnaires - Epworth Sleepiness Scale, which is a subjective measurement of daytime sleepiness, and the Richards-Campbell Sleep Questionnaire, which evaluates sleep depth, efficiency, and quality. The questionnaires will be carried out on each study day either face-to-face or over the phone depending on participant availability.
Intervention code [1] 313522 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318895 0
Feasibility of studying sleep in this patient population at RMH.

This composite primary outcome will be assessed by measuring:
- Monthly recruitment rate
- Number of eligible patients to enrolled patients
- Reasons for exclusion
- Reliability of data collection
- Complete follow up
Timepoint [1] 318895 0
Assessed primarily at enrollment, and at completion of the study.
Secondary outcome [1] 366357 0
Assessment of the frequency of sleep disorders in the critically ill patient population.

This outcome will be assessed by both objectively and subjectively measuring sleep (via methods including EEG, EMG, and EOG, actigraphy, portable polysomnography, Epworth Sleepiness Scale, and Richards-Campbell Sleep Questionnaire) to identify whether a sleep disorder exists.

These sleep measurements will be analysed in combination and inspected to determine the frequency of sleep disorders.

Timepoint [1] 366357 0
Assessed at three defined timepoints - during ICU stay, during stay on the ward, and at patient's home assessed 90 days post-hospital discharge.
Secondary outcome [2] 366360 0
Objective measure of sleep, including number of minutes spent asleep and in various sleep stages.

This will be assessed using EEG, EOG and EMG (in hospital), and portable polysomnography (in participant's home).
Timepoint [2] 366360 0
Once overnight in ICU (>5 days following ICU admission), once overnight on the ward, and once in the participant's home (>90 days following hospital discharge).
Secondary outcome [3] 366431 0
Objective measure of sleep, including number of minutes spent active, at rest, and asleep.

This will be assessed using an actigraphy device.
Timepoint [3] 366431 0
Once overnight in ICU (>5 days following ICU admission), once overnight on the ward, and for 7 days in the participant's home (>90 days following hospital discharge).
Secondary outcome [4] 366432 0
Subjective measure of sleep, assessed using the Epworth Sleepiness Score (a subjective measure of daytime sleepiness).
Timepoint [4] 366432 0
During ICU admission (if appropriate), post ICU discharge (in hospital), and 90 days post hospital discharge.
Secondary outcome [5] 366499 0
Subjective measure of sleep, assessed using the Richards-Campbell Sleep Questionnaire (a subjective measure of sleep depth, latency, efficiency, and quality).
Timepoint [5] 366499 0
During ICU admission (if appropriate), post ICU discharge (in hospital), and 90 days post hospital discharge.

Eligibility
Key inclusion criteria
Critically-ill patients admitted to ICU
Aged >18 years
Treated in RMH ICU for >/= 5 calendar days total
Expected to remain in ICU for at least one more night
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a previously diagnosed sleeping disorder
Patients with normal residence >50km from RMH
Patients unlikely to survive 3 months from the first study day in ICU
Patients unlikely to be discharged home within 3 months of the first study day in ICU
Patients receiving thiopentone to achieve 'EEG burst suppression'
Patients currently being treated for status epilepticus
Patients whose ICU admission was a planned admission post-elective surgery
Pregnancy
Patients who are unable to provide informed consent via self or MTDM
Patients who lack decision making capacity and are unable to identify a MTDM

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis
Depending on distribution we will report point estimates using mean (SD) or median [IQR] and, for proportions n (%).

To assess these data we will undertake initial exploratory data analyses involving calculation of summary statistics (non-parametric as appropriate), inspection of scatterplot matrices comprising all the scores from various methods of sleep measurement, for identification of possible linear correlation or non-linear relationships, and construction of trajectory plots for those scores of most interest. Where possible, agreement and bias between various continuous scores measuring the same aspect of sleep (e.g. sleep onset latency or total sleep time) will be assessed by the limits of agreement method of Bland and Altman. Non-continuous categorical sleep scores may be compared using chance – adjusted measures of agreement (bias- and prevalence-adjusted kappa. Following inspection of these plots and the above initial assessment of agreement between methods, we are likely to evaluate differences over time with a logistic model using generalized estimating equation (GEE) for binary data (proportions). Assessment of change in continuous data will depend on data distribution. If approximately normal, these data would be assessed using a linear regression model with time points of interest, and again the use of the GEE approach to deal with the internal correlation. If skew we will attempt log transformation to analyze geometric mean results as above.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13022 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 25508 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 301830 0
Hospital
Name [1] 301830 0
Royal Melbourne Hospital
Address [1] 301830 0
Royal Melbourne Hospital, 300 Grattan Street, Parkville, Victoria, 3050
Country [1] 301830 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
Royal Melbourne Hospital, 300 Grattan Street, Parkville, Victoria, 3050
Country
Australia
Secondary sponsor category [1] 301573 0
None
Name [1] 301573 0
N/A
Address [1] 301573 0
Nil
Country [1] 301573 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302532 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 302532 0
Office for Research The Royal Melbourne Hospital Level 2 South West 300 Grattan Street, Parkville, Victoria, 3050
Ethics committee country [1] 302532 0
Australia
Date submitted for ethics approval [1] 302532 0
Approval date [1] 302532 0
19/11/2018
Ethics approval number [1] 302532 0
HREC/45507/MH-2018

Summary
Brief summary
Disturbances of sleep occur frequently in the critically ill. Much less is known as to whether sleep disturbance is acute and resolves as patients recover, or is an issue that persists after hospital discharge and continues to adversely affect patients.
Studies using patient subjective assessment suggest that sleep disturbances persist. However, only 28 patients in total (3 studies) have used objective measures (e.g. polysomnography) in ICU survivors to measure sleep, and in none of these three studies were measurements taken in ICU or hospital.
This study will provide novel data as it will be the first comprehensive and objective longitudinal assessment of sleep disturbances in patients admitted to ICU.
This inception cohort study will determine feasibility of objectively and subjectively measuring sleep, provide estimates of the proportion of long-stay ICU patients who have a new sleep disorder and evaluate whether sleep changes over time during critical illness and recovery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90546 0
A/Prof Adam Deane
Address 90546 0
Level 5, Building B The Royal Melbourne Hospital 300 Grattan Street, Parkville Victoria 3050
Country 90546 0
Australia
Phone 90546 0
+61 3 9342 9254
Fax 90546 0
Email 90546 0
adam.deane@mh.org.au
Contact person for public queries
Name 90547 0
Ms Deborah Barge
Address 90547 0
Level 5, Building B The Royal Melbourne Hospital 300 Grattan Street, Parkville Victoria 3050
Country 90547 0
Australia
Phone 90547 0
+61 3 9342 9235
Fax 90547 0
Email 90547 0
deborah.barge@mh.org.au
Contact person for scientific queries
Name 90548 0
A/Prof Adam Deane
Address 90548 0
Level 5, Building B The Royal Melbourne Hospital 300 Grattan Street, Parkville Victoria 3050
Country 90548 0
Australia
Phone 90548 0
+61 3 9342 9254
Fax 90548 0
Email 90548 0
adam.deane@mh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
At this stage, no IPD will be available
What supporting documents are/will be available?
Study protocol
Ethical approval
How or where can supporting documents be obtained?
Type [1] 6568 0
Study protocol
Citation [1] 6568 0
Link [1] 6568 0
Email [1] 6568 0
deborah.barge@mh.org.au
Other [1] 6568 0
Attachment [1] 6568 0
Type [2] 6569 0
Ethical approval
Citation [2] 6569 0
Link [2] 6569 0
Email [2] 6569 0
deborah.barge@mh.org.au
Other [2] 6569 0
Attachment [2] 6569 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary