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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 in healthy drivers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000263099
Enrollment
32
Registered
2010-03-31
Start date
2009-04-01
Completion date
Unknown
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

The results of the study will examine the association between performance impairment on a simulated driving task and eye measures of drowsiness, induced by acute sleep loss, alcohol and hypnotic drug administration. These findings will help to determine the validity of eye measures as a countermeasure to fatigue-states, with the aim of reducing sleep-related motor vehicle accidents.

Interventions

Three treatment arms completed in random order by each participant, with treatments separated by at least one week: 1) Single 20mg dose Temazepam administered orally & observed for 5hrs; 2)Orally administered alcohol doses resulting in two peak blood alcohol concentrations (BACs), 0.05% & 0.08%, observed for 8hrs total with 1.5hrs between peak BACs; 3) Restricted sleep (4hrs) observed for 8hrs.

Sponsors

Institute for Breathing and Sleep
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used)

Eligibility

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

Inclusion criteria

1) Current Australian driving licence, provisional or unrestricted; 2) 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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026