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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] 289378 0
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 299015 0
Condition category
Condition code
Other 299074 299074 0 0
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] 294965 0
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] 298547 0
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] 298547 0
Each day after spending a night in ICU.
Primary outcome [2] 298594 0
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] 298594 0
Each day after spending a night in ICU.
Secondary outcome [1] 324542 0
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] 324542 0
Night time in ICU.
Secondary outcome [2] 324674 0
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] 324674 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
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)
NSW
Recruitment hospital [1] 5918 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment postcode(s) [1] 13366 0
2305 - New Lambton Heights

Funding & Sponsors
Funding source category [1] 293759 0
Government body
Name [1] 293759 0
Innovation Scholarship Fund of the Hunter New England Local Health District
Address [1] 293759 0
John Hunter Hospital
Lookout Rd.,
New Lambton Heights, 2305, NSW
Country [1] 293759 0
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] 292587 0
Hospital
Name [1] 292587 0
Critical Care Services Department
Address [1] 292587 0
John Hunter Hospital
Lookout Rd.,
New Lambton Heights, 2305, NSW
Country [1] 292587 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295194 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 295194 0
John Hunter Hospital
Lookout Rd.,
New Lambton Heights, 2305, NSW
Ethics committee country [1] 295194 0
Australia
Date submitted for ethics approval [1] 295194 0
15/06/2016
Approval date [1] 295194 0
31/08/2016
Ethics approval number [1] 295194 0

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 66470 0
Dr F. Eduardo Martinez
Address 66470 0
Intensive Care Unit, John Hunter Hospital
Lookout Rd.
New Lambton Heights, NSW 2305
Country 66470 0
Australia
Phone 66470 0
+612 4921 4241
Fax 66470 0
Email 66470 0
ed.martinez@hnehealth.nsw.gov.au
Contact person for public queries
Name 66471 0
Dr F. Eduardo Martinez
Address 66471 0
Intensive Care Unit, John Hunter Hospital
Lookout Rd.
New Lambton Heights, NSW 2305
Country 66471 0
Australia
Phone 66471 0
+612 4921 4241
Fax 66471 0
Email 66471 0
ed.martinez@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 66472 0
Dr F. Eduardo Martinez
Address 66472 0
Intensive Care Unit, John Hunter Hospital
Lookout Rd.
New Lambton Heights, NSW 2305
Country 66472 0
Australia
Phone 66472 0
+612 4921 4241
Fax 66472 0
Email 66472 0
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?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
Summary results
No Results