CompletedPhase 4ACTRN12609000289213

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


Sponsor

Austin Health

Enrollment

32 participants

Start Date

Apr 1, 2009

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 50 Yearss

Inclusion Criteria1

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

Exclusion Criteria13

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

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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 6

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).


Locations(1)

Australia

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ACTRN12609000289213