ANZCTR - Registration

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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]

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

sleep disruption.

Condition category

Condition code

Emergency medicine

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]

Not applicable

Comparator / control treatment

None

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Sleep quality in mechanically ventilated patients

Timepoint [1]

Up to 17 hours on Polysomnography monitoring, generally planned from 4 PM to 9AM the following day.

Secondary outcome [1]

No secondary outcomes planned

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Frankston Hospital - Frankston

Recruitment postcode(s) [1]

3199 - Frankston

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

The Angior Family Foundation

Address [1]

Country [1]

Australia

Primary sponsor type

Hospital

Name

Peninsula Health, Frankston Hospital

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Peninsula Health Human Research Ethics Committee

Ethics committee address [1]

https://www.peninsulahealth-research.org.au/ethics/human-research-ethics-committee/

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/05/2023

Approval date [1]

12/02/2024

Ethics approval number [1]

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

Dr Ravindranath Tiruvoipati

Address

Department of Intensive Care Medicine, Frankston Hospital, Frankston,VIC 3199

Country

Australia

Phone

+61 431279347

Fax

[email protected]

Contact person for public queries

Name

Ravindranath Tiruvoipati

Address

Department of Intensive Care Medicine, Frankston Hospital, Frankston,VIC 3199

Country

Australia

Phone

+61 431279347

Fax

[email protected]

Contact person for scientific queries

Name

Ravindranath Tiruvoipati

Address

Department of Intensive Care Medicine, Frankston Hospital, Frankston,VIC 3199

Country

Australia

Phone

+61 431279347

Fax

[email protected]

Data sharing statement

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

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.	Type	Citation	Link	Email	Other Details	Attachment
21692	Ethical 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

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically