Validating fatigue crash risk and ocular measures of alertness in drivers

Not Applicable

Recruiting

• Conditions: sleep deprivation risks; Public Health - Health promotion/education; Neurological - Studies of the normal brain and nervous system; Mental Health - Studies of normal psychology, cognitive function and behaviour

• Registration Number: ACTRN12612000102875
• Lead Sponsor: Institute for Breathing and Sleep

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

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)

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).[Following the first PVT and KDT tasks.];Ocular measures: (1) of drowsiness, via Optalert system. (2) visual scanning, via the iView-X.[(1) Optalert measures of drowsiness will be recorded across all tasks. <br>(2) iView-X eye tracking device will record visual scanning during the drive only.];Number and duration of alpha and theta periods (microsleeps) on the electrencephalogram (EEG).[Assessed across all tasks.]

Secondary Outcome Measures

Name	Time	Method
Performance on the PVT.[Undertaken twice: at the commencement of the testing session and immediately following the drive.];Performance on the KDT.[Undertaken twice: both times immediately following the two PVT tasks.];Karolinska Sleepiness Scale (KSS) scores.[(1) Pre-drive: before the PVT, between the PVT and KDT, and following the KDT. <br>(2) Drive: pre- and post-drive. <br>(3) Post-drive: before the PVT, between the PVT and KDT, and following the KDT.]