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Ocular measures for detection of driving impairment due to sleep loss, alcohol and benzodiazepine use

Ocular measures for detection of driving impairment due to sleep loss, alcohol and benzodiazepine use

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000289213
Enrollment
32
Registered
2009-05-18
Start date
2009-04-01
Completion date
2010-12-06
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will examine whether the impairing effects of sleep loss, alcohol and hypnotic drugs can be detected using a simulated driving task and drowsiness monitoring technology in the laboratory setting. The hypothesis of this study is that performance deterioration, as a result of sleep restriction and acute benzodiazepine administration, can be detected by increases in slow eyelid closure, a reduction in amplitude of eyelid opening and a reduction in saccadic eye movements, as measured by Optalert.

Interventions

All participants will undergo three randomised sessions, seperated by a 1 week washout period. 1. Sleep restriction session: sleep will be restricted to 4 hours on the night prior to testing (2am to 6am). 2. benzodiazepine session: a single, 20mg oral dose of benzodiazepine administered at 9am, 2 hours prior to testing 3. alcohol session: measured doses of vodka in orange juice will be administrered orally until a blood alcohol concentration (BAC) of 0.05% and 0.08% is reached (checked by alcome

All participants will undergo three randomised sessions, seperated by a 1 week washout period. 1. Sleep restriction session: sleep will be restricted to 4 hours on the night prior to testing (2am to 6am). 2. benzodiazepine session: a single, 20mg oral dose of benzodiazepine administered at 9am, 2 hours prior to testing 3. alcohol session: measured doses of vodka in orange juice will be administrered orally until a blood alcohol concentration (BAC) of 0.05% and 0.08% is reached (checked by alcometer). Testing will commence immediately at each alcohol level. During testing, driving simulation and a reaction time task will be completed, while ocular parameters are measured, using optalert and electrooculography (EOG).

Sponsors

Austin Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

healthy, drivers licence, alcohol intake in standard drinks >0 average <5/day for males and < 3/day for females

Exclusion criteria

1. Epilepsy 2. Diabetes requiring insulin 3. Chronic psychiatric illness 4. Visual impairment which does not correct with glasses 5. Unable to speak and read English 6. Drink more than 5 caffeinated beverages per day 7. Significant daytime sleepiness (Epworth Sleepiness Scale score > 11). 8. Chronic neurological illness 9. Chronic liver disease, diabetes requiring insulin or renal impairment 10. Pregnancy or breast feeding 11. Sleep apnoea, narcolepsy 12. Use of sedating medication 13. Anticoagulation with warfarin

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026