ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616000805471

Ethics application status

Approved

Date submitted

9/06/2016

Date registered

21/06/2016

Date last updated

27/11/2018

Date data sharing statement initially provided

27/11/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Implementation of a sleep management plan to improve the quality and quantity of sleep in the Intensive Care Unit: a before and after study (iSleep)

Scientific title

Implementation of a sleep management plan to improve the quality and quantity of sleep in ICU: a before and after study (iSleep)

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

iSleep

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Poor sleep in the critically ill

Condition category

Condition code

Other

Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Implementation of a sleep management plan in ICU: This will involve educating ICU staff about the importance of sleep in the critically ill through education sessions and in-services, implementing a nightly schedule to reduce the volumes of monitors, ventilators, telephones, and pagers in the ICU, dimming the lights in the ICU and patient rooms, closing patient rooms curtains, and providing patients with eye masks and ear plugs if they wish to have them.
Education sessions will be administered by senior ICU medical and nursing staff. The intervention will take place for 4 months before data is collected again and while the after data is being collected. This will be a total of 6 months. Teaching sessions will occur for one hour, at least once a week. If on a particular week attendance by nursing staff is deemed by the investigators to be too low (less than five ICU nurses), then catch-up sessions will be scheduled on the following week for the same duration of the normal session and done in the same manner. This will be provided in group sessions. They will occur face to face during formal ICU education sessions. The adherence to the strategy will be logged through the ICU education program attendance checks
The sleep management plan will remain in place in the ICU for the duration of the "after" data collection period.

Intervention code [1]

Behaviour

Comparator / control treatment

The comparator will be a "before" period where the ICU will perform current standard practice. Data will be collected prospectively and then used to compare to the "after" period.

Control group

Active

Outcomes

Primary outcome [1]

Patient perception of sleep quality in the ICU. This outcome will be assessed using a standardized, validated questionnaire that has been previously reported in the medical literature.
The name of the questionnaire is "Sleep quality in the intensive care unit",
reference: Little A, Ethier C. "A patient survey of sleep quality in the intensive care unit." Minerva Aneasthesiol. 2012 Apr; 78 (4): 406-14.

Timepoint [1]

Each day after spending a night in ICU.

Primary outcome [2]

Patient perception of sleep quantity in the ICU. This outcome will be assessed using a standardized, validated questionnaire that has been previously reported in the medical literature.
The name of the questionnaire is "Sleep quality in the intensive care unit",
reference: Little A, Ethier C. "A patient survey of sleep quality in the intensive care unit." Minerva Aneasthesiol. 2012 Apr; 78 (4): 406-14.

Timepoint [2]

Each day after spending a night in ICU.

Secondary outcome [1]

Light levels in the ICU. These will be measured using calibrated, industrial light level monitors. Measurements will be taken inside patient rooms and at nurses' station each night and the average light levels will be reported.

Timepoint [1]

Night time in ICU.

Secondary outcome [2]

Sound levels in the ICU. These will be measured using calibrated, industrial sound level monitors. Measurements will be taken inside patient rooms and at nurses' station each night and the average sound levels will be reported.

Timepoint [2]

Night time in ICU.

Eligibility

Key inclusion criteria

Adult patients, admitted to the intensive care unit, patients cognitively able to answer a survey about sleep quality and quantity in the intensive care unit, patients who give informed consent

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Under 18 years of age, cardiothoracic patients, patients expected to die during ICU admission, neurological deficits that might keep patients from answering the survey, patients being mechanically ventilated.

Study design

Purpose of the study

Prevention

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

No allocation concealment. Patients presenting to ICU during the before period will go on the "before" arm, patients presenting to ICU during the after period will go on the "after" arm.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

None

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

The sample size of 350, 175 in each arm, is to give enough statistical power to detect a significant difference given an alpha of 0.05 and beta of 0.8 in the main question of the survey which is about quality of sleep in the ICU.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

18/07/2016

Actual

14/06/2017

Date of last participant enrolment

Anticipated

27/12/2019

Actual

Date of last data collection

Anticipated

2/03/2020

Actual

Sample size

Target

350

Accrual to date

145

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

John Hunter Hospital Royal Newcastle Centre - New Lambton

Recruitment postcode(s) [1]

2305 - New Lambton Heights

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Innovation Scholarship Fund of the Hunter New England Local Health District

Address [1]

John Hunter Hospital
Lookout Rd.,
New Lambton Heights, 2305, NSW

Country [1]

Australia

Primary sponsor type

Hospital

Name

Intensive Care Unit, John Hunter Hospital

Address

Intensive Care Unit, John Hunter Hospital
Lookout Rd.,
New Lambton Heights, 2305, NSW

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Critical Care Services Department

Address [1]

John Hunter Hospital
Lookout Rd.,
New Lambton Heights, 2305, NSW

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

John Hunter Hospital
Lookout Rd.,
New Lambton Heights, 2305, NSW

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/06/2016

Approval date [1]

31/08/2016

Ethics approval number [1]

Summary

Brief summary

Sleep is a very important physiological process that helps the body heal when sick. The ICU environment is not conducive to achieving good quality sleep. Loud noise levels and bright lights during the night time are some of the things that keep patients form achieving a good night sleep.
This study will be a before and after trial where patients will be given the chance to answer a validated questionnaire about the quality and quantity of sleep that they achieved during every night spent in ICU. Sound levels and light levels will be measured inside patient rooms and at the nurses station at night. An intervention will then take place, which will be the implementation of a sleep management plan in ICU. This will include changing the culture of the unit to try and achieve low noise and light levels at night, implementing a schedule to decrease the volume of monitors and ventilators in the ICU as well as dimming and turning off lights at night. Patients will be offered eye masks and ear plugs to wear at night. Once the sleep management plan has become ingrained, a second period of data collection will take place where patient will answer the same questionnaire and noise and light levels at the nurses' station and patient rooms will again be measured. We hope to find a significant decrease in all measurements.

Trial website

Nil

Trial related presentations / publications

Nil

Public notes

Contacts

Principal investigator

Name

Dr F. Eduardo Martinez

Address

Intensive Care Unit, John Hunter Hospital
Lookout Rd.
New Lambton Heights, NSW 2305

Country

Australia

Phone

+612 4921 4241

Fax

ed.martinez@hnehealth.nsw.gov.au

Contact person for public queries

Name

F. Eduardo Martinez

Address

Intensive Care Unit, John Hunter Hospital
Lookout Rd.
New Lambton Heights, NSW 2305

Country

Australia

Phone

+612 4921 4241

Fax

ed.martinez@hnehealth.nsw.gov.au

Contact person for scientific queries

Name

F. Eduardo Martinez

Address

Intensive Care Unit, John Hunter Hospital
Lookout Rd.
New Lambton Heights, NSW 2305

Country

Australia

Phone

+612 4921 4241

Fax

ed.martinez@hnehealth.nsw.gov.au

Data sharing statement

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

Yes

What data in particular will be shared?

questionnaires

When will data be available (start and end dates)?

When the final manuscript is submitted to peer-reviewed journals

Available to whom?

anyone

Available for what types of analyses?

any

How or where can data be obtained?

Upon request to the corresponding author

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.

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