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Trial registered on ANZCTR


Registration number
ACTRN12609000289213
Ethics application status
Approved
Date submitted
4/12/2008
Date registered
18/05/2009
Date last updated
18/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ocular measures for detection of driving impairment due to sleep loss, alcohol and benzodiazepine use
Scientific title
Ocular measures for detection of driving impairment due to sleep loss, alcohol and benzodiazepine use
Secondary ID [1] 283611 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sleep- and drug-related motor vehicle accident risk 4062 0
healthy volunteers 4384 0
Condition category
Condition code
Injuries and Accidents 4270 4270 0 0
Other injuries and accidents
Public Health 4631 4631 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 3784 0
Behaviour
Comparator / control treatment
Alll participants will also complete baseline testing durng each session:
Sleep restriction session: testing after a normal night of sleep
benzodiazepine session: testing following a single acute oral dose of 20mg placebo (lactose)
alcohol session: testing at baseline, prior to alcohol administration (BAC = 0.00%)
Control group
Placebo

Outcomes
Primary outcome [1] 5155 0
ocular measures tested by Optalert: slow eyelid closure, blink amplitude, saccades, EOG
Timepoint [1] 5155 0
baseline, following intervention during each session
Secondary outcome [1] 8674 0
driving performance using the AusEd driving simulator: lane position variability
Timepoint [1] 8674 0
baseline, following intervention in each session

Eligibility
Key inclusion criteria
healthy, drivers licence, alcohol intake in standard drinks >0 average <5/day for males and < 3/day for females
Minimum age
18 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential particpants will undergo a medical examination, and those who meet the inclusion criteria will be given a randomisation number. Each participant will complete each of the three sessions; the randomisation number indicates the order in which the sessions will be completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence is created by the pharmacy at Austin Health.The sequence will be generated using a simple computerised sequence randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4243 0
Self funded/Unfunded
Name [1] 4243 0
Institute for Breathing & Sleep
Address [1] 4243 0
Studley Rd, Heidelberg, Victoria 3084
Country [1] 4243 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Studley Rd, Heidelberg, Victoria 3084
Country
Australia
Secondary sponsor category [1] 4494 0
None
Name [1] 4494 0
Address [1] 4494 0
Country [1] 4494 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6609 0
Austin Health Human Ethics Comittee
Ethics committee address [1] 6609 0
Research Ethics Unit
Level 8 HSB Room 8322
Austin Health
Heidelberg, Victoria 3084
Ethics committee country [1] 6609 0
Australia
Date submitted for ethics approval [1] 6609 0
05/12/2008
Approval date [1] 6609 0
26/10/2010
Ethics approval number [1] 6609 0
3435

Summary
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.
Trial website
Trial related presentations / publications
Wilkinson VE, Jackson ML, Barnes M, Stevens B, Westlake J, Stevens B, Swann P, Rajaratnam S, Howard ME. (in press).The accuracy of eyelid movement parameters for detecting behavioral lapses following sleep restriction. Journal of Clinical Sleep Medicine. Accepted 14th September, 2013.

Wilkinson VE, Jackson ML, Barnes M, Stevens B, Westlake J, Swann P, Howard ME. (2012). Perception of driving ability is impaired by sleep enhancing medication. Sleep & Biological Rhythms, 10 (Supp 1): 6.

Howard ME, Wilkinson VE, Jackson ML, Barnes M, Stevens B, Westlake J, Swann P, Rajaratnam SW. (2012). The accuracy of eyelid movement parameters for detecting lapses following sleep restriction. Sleep, 35: A108.

Wilkinson VE, Jackson ML, Barnes M, Stevens B, Westlake J, Swann P, Howard ME. (2012). Changes in ocular measures due to benzodiazepines and alcohol consumption. Occupational Safety in Transport (OSIT) Conference.
Public notes

Contacts
Principal investigator
Name 29194 0
Dr Mark Howard
Address 29194 0
Institute for Breathing and Sleep, Austin Health
Heidelberg, Victoria, 3084
Country 29194 0
Australia
Phone 29194 0
+613 9496 3877
Fax 29194 0
Email 29194 0
mark.howard@austin.org.au
Contact person for public queries
Name 12351 0
Dr Melinda Jackson
Address 12351 0
Institute for Breathing & Sleep
Studley Rd, Heidelberg, Victoria 3084
Country 12351 0
Australia
Phone 12351 0
+613 9496 3528
Fax 12351 0
Email 12351 0
melinda.jackson@austin.org.au
Contact person for scientific queries
Name 3279 0
Ms Bronwyn Stevens
Address 3279 0
Institute for Breathing & Sleep
Studley Rd, Heidelberg, Victoria 3084
Country 3279 0
Australia
Phone 3279 0
+613 9496 3528
Fax 3279 0
Email 3279 0
bronwyn.stevens@austin.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary