Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001307594
Ethics application status
Approved
Date submitted
9/10/2024
Date registered
28/10/2024
Date last updated
28/10/2024
Date data sharing statement initially provided
28/10/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Sleep Quality in Critical Care
Scientific title
Sleep Quality in Critical Care: Effect of overnight use of ear plugs on sleep quality in intensive care unit (ICU) patients
Secondary ID [1] 313156 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep quality 335435 0
Delirium 335436 0
Condition category
Condition code
Public Health 331996 331996 0 0
Health service research
Neurological 332084 332084 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention arm: Use of ear plugs overnight by eligible ICU patients
The intervention group will be supplied with foam earplugs (3M Classic foam earplug) to be used from 22:00 to 06:00 hours, for 2 nights.
Participants will be asked to complete the Richards Campbell Sleep Questionnaire (RSCQ) on the morning of the 3rd day.
Hours of ear plug use will be recorded, with ICU nurse to monitor for ear plugs being in situ during regular overnight observations
Hours of sleep/wake will be recorded, with ICU nurse to monitor for sleep / wake during regular overnight observations
Participants will be screened twice daily by ICU trained nurses using the validated Confusion Assessment Method (CAM). Staff conducting CAM assessments are not blinded. CAM assessment once per shift is standard care.
Intervention code [1] 329726 0
Prevention
Intervention code [2] 329793 0
Treatment: Other
Comparator / control treatment
Control arm: No ear plugs in eligible ICU patients
The control group who will receive usual care over 2 nights.
Participants will be asked to complete the Richards Campbell Sleep Questionnaire (RSCQ) on the morning of the 3rd day.
Hours of sleep/wake will be recorded.
Participants will be screened twice daily by ICU trained nurses using the validated Confusion Assessment Method (CAM). Staff conducting CAM assessments are not blinded. CAM assessment once per shift is standard care.
Control group
Active

Outcomes
Primary outcome [1] 339596 0
Sleep quality
Timepoint [1] 339596 0
On morning of 3rd day as inpatient in the ICU
Secondary outcome [1] 440542 0
Incidence of delirium
Timepoint [1] 440542 0
Twice daily for 3 consecutive days as an inpatient in the ICU

Eligibility
Key inclusion criteria
1. adults aged 18 years and over;
2. expected length of stay in the ICU of more than 48 hours;
3. ability of patients to communicate verbally and understand the sleep questionnaire; and
4. able to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Mechanically ventilated and sedated patients;
2. pre-existing cognitive impairment in the medical record;
3. contraindications for use of ear plugs e.g acute brain injury as ICU admission diagnosis, use of hearing aids; and
4. prior enrolment.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation via selecting an envelope at random
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed by the statistician on the research team using Stata.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
17/04/2024
Date of last participant enrolment
Anticipated
29/12/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
90
Accrual to date
18
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317598 0
Charities/Societies/Foundations
Name [1] 317598 0
South Eastern Sydney Local Health District RES-ON Research Funding Program
Country [1] 317598 0
Australia
Primary sponsor type
Individual
Name
Dr Anas Naeem
Address
Country
Australia
Secondary sponsor category [1] 319906 0
Government body
Name [1] 319906 0
South Eastern Sydney Local Health District
Address [1] 319906 0
Country [1] 319906 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316303 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 316303 0
Ethics committee country [1] 316303 0
Australia
Date submitted for ethics approval [1] 316303 0
14/12/2023
Approval date [1] 316303 0
12/04/2024
Ethics approval number [1] 316303 0

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

Contacts
Principal investigator
Name 137458 0
Dr Anas Naeem
Address 137458 0
Dept of Critical Care Medicine, Sutherland Hospital, Kingsway, Caringbah NSW 2229
Country 137458 0
Australia
Phone 137458 0
+61 2 9540 7238
Fax 137458 0
Email 137458 0
[email protected]
Contact person for public queries
Name 137459 0
Elizabeth Turner
Address 137459 0
Dept of Critical Care Medicine, Sutherland Hospital, Kingsway, Caringbah NSW 2229
Country 137459 0
Australia
Phone 137459 0
+61 2 9540 7886
Fax 137459 0
Email 137459 0
[email protected]
Contact person for scientific queries
Name 137460 0
Dr Anas Naeem
Address 137460 0
Dept of Critical Care Medicine, Sutherland Hospital, Kingsway, Caringbah NSW 2229
Country 137460 0
Australia
Phone 137460 0
+61 2 9540 7238
Fax 137460 0
Email 137460 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


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.