Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000338561
Ethics application status
Approved
Date submitted
20/02/2024
Date registered
26/03/2024
Date last updated
26/03/2024
Date data sharing statement initially provided
26/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating sleep quality in patients admitted to intensive care unit.
Scientific title
Evaluation of drug induced sleep quality in critically ill patients using polysomnography
Secondary ID [1] 311575 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep in Critically ill patients 332949 0
sleep disruption. 333184 0
Condition category
Condition code
Emergency medicine 329662 329662 0 0
Other emergency care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The aim is to investigate the drug induced sleep quality in critically ill patients using polysomnography. Patients will be receiving drug(s) to assist with their management including sedation regardless of their involvement in this study. The drugs that are used for sedation in intensive care include Dexmedetomidine, melatonin, Lemborexant, gabapentin, Fentanyl, propofol or midazolam. These drugs are given to the duration of patients while they require mechanical ventilation. For the purpose of this study, we specifically will assess Dexmedetomidine, melatonin, Lemborexant, gabapentin for 3 days only with polysomnography that studies brain electrical activity to help in understanding the sleep quality.
Intervention code [1] 328026 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337449 0
Sleep quality in mechanically ventilated patients
Timepoint [1] 337449 0
Up to 17 hours on Polysomnography monitoring, generally planned from 4 PM to 9AM the following day.
Secondary outcome [1] 431927 0
No secondary outcomes planned
Timepoint [1] 431927 0
Not applicable

Eligibility
Key inclusion criteria
Patients are on invasive mechanical ventilation and are expected to stay on the mechanical ventilator for at least 72 hours from the time of study inclusion.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients currently requiring paralytic agents, suspected to have ongoing seizures, admitted with a diagnosis of stroke, Guillain Barre Syndrome, traumatic brain injury current or past, cardiac arrest,

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Data analysis will largely be descriptive. Where possible comparisons will be performed to compare sleep stages (REM time, N1 time, N2 time, N3 times) with various drugs that are tested in this study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/04/2024
Actual
Date of last participant enrolment
Anticipated
30/06/2026
Actual
Date of last data collection
Anticipated
31/03/2027
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26189 0
Frankston Hospital - Frankston
Recruitment postcode(s) [1] 42065 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 315874 0
Charities/Societies/Foundations
Name [1] 315874 0
The Angior Family Foundation
Country [1] 315874 0
Australia
Primary sponsor type
Hospital
Name
Peninsula Health, Frankston Hospital
Address
Country
Australia
Secondary sponsor category [1] 318016 0
None
Name [1] 318016 0
Address [1] 318016 0
Country [1] 318016 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314722 0
Peninsula Health Human Research Ethics Committee
Ethics committee address [1] 314722 0
https://www.peninsulahealth-research.org.au/ethics/human-research-ethics-committee/
Ethics committee country [1] 314722 0
Australia
Date submitted for ethics approval [1] 314722 0
22/05/2023
Approval date [1] 314722 0
12/02/2024
Ethics approval number [1] 314722 0
HREC/82409/PH-2023

Summary
Brief summary
Sleep is an important activity for ensuing health and recovery from illness. Sleep deprivation is known to be associated with several comorbidities including obesity, diabetes, anxiety and depression, hypertension, heart disease and stroke and increased risk of death. Sleep deprivation is also known to be associated with impaired cognition, impaired immune function and could make people less morally aware.
Sleep in intensive care unit (ICU) was shown to be of a poor quality by several studies including from our group. However many of these studies assessed sleep using subjective tools such as Richard Campbell Sleep Questionnaire, self-reported sleep quality by patients and nurse, or clinician observations. These subjective tools, while they are simpler to use, are not reliable and can over- or underestimate the sleep quality and duration. Some objective tools such as Actigrapy and Bispectral Index were used for sleep evaluation but are not gold standard to evaluate sleep. In this study we propose to use Polysomnography which is considered to be gold standard for studying sleep. We aim to study the sleep of patients who are on a mechanical ventilator and receiving some of the commonly used drugs to promote sleep.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132522 0
Dr Ravindranath Tiruvoipati
Address 132522 0
Department of Intensive Care Medicine, Frankston Hospital, Frankston,VIC 3199
Country 132522 0
Australia
Phone 132522 0
+61 431279347
Fax 132522 0
Email 132522 0
[email protected]
Contact person for public queries
Name 132523 0
Ravindranath Tiruvoipati
Address 132523 0
Department of Intensive Care Medicine, Frankston Hospital, Frankston,VIC 3199
Country 132523 0
Australia
Phone 132523 0
+61 431279347
Fax 132523 0
Email 132523 0
[email protected]
Contact person for scientific queries
Name 132524 0
Ravindranath Tiruvoipati
Address 132524 0
Department of Intensive Care Medicine, Frankston Hospital, Frankston,VIC 3199
Country 132524 0
Australia
Phone 132524 0
+61 431279347
Fax 132524 0
Email 132524 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
We have not had approval from either the HREC or have this considered in our research team.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21692Ethical approval    387366-(Uploaded-20-02-2024-13-48-59)-Study-related document.doc



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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