ANZCTR - Registration

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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]

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

Condition category

Condition code

Public Health

Epidemiology

Other

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]

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]

Total sleep time

Timepoint [1]

A 24 hour sleep period using continuous monitoring

Secondary outcome [1]

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]

24 hour sleep monitoring

Secondary outcome [2]

Quantity (percentage) of each sleep stage (1 to 4 and Rapid Eye Movement)

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Australian College of Critical Care Nurses

Address [1]

PO Box 219, Carlton South, VIC 3053

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Intensive Care Foundation

Address [2]

Level 2, 10 Ievers Terrace
Carlton, Victoria 3053, Australia

Country [2]

Australia

Primary sponsor type

University

Name

University of Technology Sydney

Address

15 Broadway,
Ultimo, NSW 2007

Country

Australia

Secondary sponsor category [1]

Charities/Societies/Foundations

Name [1]

Northcare

Address [1]

PO Box 3553
Erina
NSW 2250

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Harbour Human Research Ethics Comittee of Northern Sydney Central Coast Health

Ethics committee address [1]

The Research Office
Royal North Shore Hospital
St Leonards
NSW 2065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/08/2008

Approval date [1]

18/09/2008

Ethics approval number [1]

0809-201M (SP)

Ethics committee name [2]

UTS Human Research Ethics Committee

Ethics committee address [2]

Research and Innovation Office 
University of Technology Sydney
Level 14, Tower Building
Broadway NSW 2007

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

25/08/2008

Approval date [2]

Ethics approval number [2]

2008-292-R

Summary

Brief summary

Intensive care units (ICU) provide treatment and care to critically ill patients. Frequently, invasive monitoring and intrusive treatments delivered via artificial airways are required, which limit the ability to communicate. These factors, symptoms of illness and the busy environment may lead to discomfort, in particular the inability to sleep. The adverse health effects of poor quality sleep are understood and ICU patients are in greater need of sleep. 

Therefore, the aim of this study is to minimise sleep disruptions and improve the quality and quantity of ICU patients’ sleep. Thirty intensive care patients’ sleep has been measured using a portable sleep monitor. Simultaneous records were made of interruptions to the patients’ sleep and sound and light levels. The results from the first group have been discussed with ICU health care personnel who have decided which sleep promoting practices to implement, i.e. organisational and behavioural changes, such as blocks of uninterrupted time and noise reduction. Sleep data will be collected on a further thirty patients to assess the effectiveness of these interventions.

No studies of this type have been conducted in Australian ICUs and few published studies have been performed with the purpose of improving sleep for ICU patients. This study is a unique opportunity to obtain data on ICU patients’ sleep in Australia using the most objective measure available, polysomnograph. It also has the potential to provide data on the effectiveness of sleep promoting activities.

Trial website

Trial related presentations / publications

Elliott, R, McKinley, S. 2014, 'The development of a clinical practice guideline to improve sleep in intensive care patients: a solution focused approach', Intensive Crit Care Nurs, vol. 30, no. 5, pp. 246-256.
Elliott R, Rai, T, McKinley 2014, ‘Factors affecting sleep in the critically ill: an observational study’, Journal of Critical Care, 29(5):859-863 Oct 2014
Elliott R, McKinley S, Fien M, Cistulli PA. An Intervention Study To Improve Sleep In The Critical Care Setting. C96 INNOVATIONS IN PULMONARY, CRITICAL CARE, AND SLEEP: American Thoracic Society International Conference; 2013. p. A4973-A.
Elliott R, McKinley S, Cistulli P, Fien M. ‘Characterisation of sleep in intensive care using 24 hour polysomnography: an observational study’, Critical Care, 2013, 17:R46
Elliott R, McKinley S, Cistulli P, Fien, M. ‘A study to improve the quality and quantity of sleep for patients in an Australian ICU is inconclusive’, Conference presentation (nursing free paper), the 36th Australian and New Zealand Annual Scientific Meeting on Intensive Care, Brisbane, Australia, October 2011. Awarded ACCCN Nursing Scholarship prize.
Elliott R, McKinley S, Cistulli P, Fien M. ‘ICU patients’ sleep in an Australian ICU is poor: A study using polysomnography’, Conference presentation (nursing free paper), The Australian and New Zealand 35th Annual Scientific Meeting on Intensive Care, Melbourne, October 2010. Awarded ACCCN Nursing Scholarship prize
Elliott R, McKinley S, Eager D. ‘A pilot study of sound levels in an Australian adult general intensive care unit’, Noise and Health, 2010 12(46):6-36. 
Elliott R, McKinley S, Eager D, Ladanyi S. ‘A pilot study of sound levels in an Australian adult general intensive care unit’, Conference presentation (nursing free paper), 34th World congress on Intensive Care, Florence, Italy, October 2009

Public notes

Contacts

Principal investigator

Name

Dr Rosalind Elliott

Address

Intensive care unit Level 6, Main Building Royal North Shore Hospital St Leonards NSW 2065

Country

Australia

Phone

+61 2 9926 4801

Fax

Rosalind.Elliott@health.nsw.gov,au

Contact person for public queries

Name

Rosalind Elliott

Address

Intensive care unit
Level 6, Main Building
Royal North Shore Hospital
St Leonards
NSW 2065

Country

Australia

Phone

++61 2 9926 4801

Fax

Rosalind.Elliott@health.nsw.gov.au

Contact person for scientific queries

Name

Rosalind Elliott

Address

Intensive care unit
Level 6, Main Building
Royal North Shore Hospital
St Leonards
NSW 2065

Country

Australia

Phone

+61 411 694 387

Fax

Rosalind.Elliott@health.nsw.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Factors affecting sleep in the critically ill: an observational study.	2014	https://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.

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Documents added automatically