Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000102875
Ethics application status
Approved
Date submitted
20/01/2012
Date registered
20/01/2012
Date last updated
24/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Validating fatigue crash risk and ocular measures of alertness in drivers
Scientific title
A comparison of rested versus sleep deprived driving performance in healthy controls on crash risk and ocular measures of alertness.
Secondary ID [1] 279657 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sleep deprivation risks 285466 0
Condition category
Condition code
Public Health 285648 285648 0 0
Health promotion/education
Neurological 285662 285662 0 0
Studies of the normal brain and nervous system
Mental Health 285663 285663 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two afternoons of testing, separated by at least one week, undertaking a series of tasks assessing driving performance, sustained attention and reaction time. Sessions will last for approximately three hours commencing at 14:30.

The sessions will be randomised between participants, however the testing order will be the same for both sessions: Psychomotor Vigilance Task (PVT), Karolinska Drowsiness Task (KDT), two hour drive on racetrack at 50km/hr, PVT, KDT.

In addition, ten professional drivers will be observed carrying out their normal driving duties for 2000km. Assessments will include lane deviation and ocular measures using Optalert. Daily measures of PVT performance and KSS scores will be taken.
Intervention code [1] 284021 0
Behaviour
Comparator / control treatment
Participants will partake in the same testing session twice, once when rested and once following a sustained wake period of 30 hours.
Control group
Active

Outcomes
Primary outcome [1] 286277 0
Driving performance: a 120 minute drive around a racetrack at a designated speed of 50km/hr. Ability to keep to the required speed limit and lane deviation will be assessed (via the AWS-1000 and manual observation/tally kept by driving instructor in the passenger seat).
Timepoint [1] 286277 0
Following the first PVT and KDT tasks.
Primary outcome [2] 286278 0
Ocular measures: (1) of drowsiness, via Optalert system. (2) visual scanning, via the iView-X.
Timepoint [2] 286278 0
(1) Optalert measures of drowsiness will be recorded across all tasks.
(2) iView-X eye tracking device will record visual scanning during the drive only.
Primary outcome [3] 286279 0
Number and duration of alpha and theta periods (microsleeps) on the electrencephalogram (EEG).
Timepoint [3] 286279 0
Assessed across all tasks.
Secondary outcome [1] 295498 0
Performance on the PVT.
Timepoint [1] 295498 0
Undertaken twice: at the commencement of the testing session and immediately following the drive.
Secondary outcome [2] 295499 0
Performance on the KDT.
Timepoint [2] 295499 0
Undertaken twice: both times immediately following the two PVT tasks.
Secondary outcome [3] 295500 0
Karolinska Sleepiness Scale (KSS) scores.
Timepoint [3] 295500 0
(1) Pre-drive: before the PVT, between the PVT and KDT, and following the KDT.
(2) Drive: pre- and post-drive.
(3) Post-drive: before the PVT, between the PVT and KDT, and following the KDT.

Eligibility
Key inclusion criteria
(1) current full driver licence (no P-plates). Driving on average more than 5000km per year.
(2) no visual problems (unless corrected by contact lenses)
Minimum age
21 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(1) high habitual caffeine intake (>300mg/day)
(2) alcohol consumption >5 standard units/week
(3) current smoker
(4) diagnosed sleep disorder (narcolpesy or sleep apnoea)
(5) medical conditions that are a contraindication to driving, eg. uncontrolled epilepsy, stroke, cardiac or respiratory disease.
(6) cognitive impairments, intellectual disability or mental illness that impairs driving ability
(7) use of sedating medications such as benzodiazepines, antihistamines and narcotic analgesics
(8) pregnant women
(9) inability to give informed consent

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284504 0
Government body
Name [1] 284504 0
VicRoads
Country [1] 284504 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Institute for Breathing and Sleep
Address
Austin Hospital
PO Box 5555
Heidelberg
Victoria 3084
Country
Australia
Secondary sponsor category [1] 283434 0
None
Name [1] 283434 0
Address [1] 283434 0
Country [1] 283434 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286486 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 286486 0
Ethics committee country [1] 286486 0
Australia
Date submitted for ethics approval [1] 286486 0
Approval date [1] 286486 0
22/12/2011
Ethics approval number [1] 286486 0
H2011 / 03994

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

Contacts
Principal investigator
Name 33575 0
Address 33575 0
Country 33575 0
Phone 33575 0
Fax 33575 0
Email 33575 0
Contact person for public queries
Name 16822 0
Justine Westlake
Address 16822 0
Institute for Breathing and Sleep
Bowen Centre
Austin Hospital
PO Box 5555
Heidelberg
Victoria 3084
Country 16822 0
Australia
Phone 16822 0
+61 3 9496 3528
Fax 16822 0
Email 16822 0
[email protected]
Contact person for scientific queries
Name 7750 0
Justine Westlake
Address 7750 0
Institute for Breathing and Sleep
Bowen Centre
Austin Hospital
PO Box 5555
Heidelberg
Victoria 3084
Country 7750 0
Australia
Phone 7750 0
+61 3 9496 3528
Fax 7750 0
Email 7750 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseEye-blink parameters detect on-road track-driving impairment following severe sleep deprivation.2019https://dx.doi.org/10.5664/jcsm.7918
EmbaseA brief assessment of eye blink drowsiness immediately prior to or following driving detects drowsiness related driving impairment.2023https://dx.doi.org/10.1111/jsr.13785
N.B. These documents automatically identified may not have been verified by the study sponsor.