ANZCTR - Registration

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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]

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

healthy volunteers

Condition category

Condition code

Injuries and Accidents

Other injuries and accidents

Public Health

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]

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]

ocular measures tested by Optalert: slow eyelid closure, blink amplitude, saccades, EOG

Timepoint [1]

baseline, following intervention during each session

Secondary outcome [1]

driving performance using the AusEd driving simulator: lane position variability

Timepoint [1]

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

Sex

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

1/03/2008

Actual

1/04/2009

Date of last participant enrolment

Anticipated

Actual

6/12/2010

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]

Self funded/Unfunded

Name [1]

Institute for Breathing & Sleep

Address [1]

Studley Rd, Heidelberg, Victoria 3084

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Health

Address

Studley Rd, Heidelberg, Victoria 3084

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Ethics Comittee

Ethics committee address [1]

Research Ethics Unit
Level 8 HSB Room 8322
Austin Health
Heidelberg, Victoria 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/12/2008

Approval date [1]

26/10/2010

Ethics approval number [1]

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

Dr Mark Howard

Address

Institute for Breathing and Sleep, Austin Health
Heidelberg, Victoria, 3084

Country

Australia

Phone

+613 9496 3877

Fax

mark.howard@austin.org.au

Contact person for public queries

Name

Melinda Jackson

Address

Institute for Breathing & Sleep
Studley Rd, Heidelberg, Victoria 3084

Country

Australia

Phone

+613 9496 3528

Fax

melinda.jackson@austin.org.au

Contact person for scientific queries

Name

Bronwyn Stevens

Address

Institute for Breathing & Sleep
Studley Rd, Heidelberg, Victoria 3084

Country

Australia

Phone

+613 9496 3528

Fax

bronwyn.stevens@austin.org.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Assessing the validity of eyelid parameters to detect impairment due to benzodiazepines	2020	https://doi.org/10.1002/hup.2723
Embase	The impact of alcohol consumption on commercial eye blink drowsiness detection technology.	2023	https://dx.doi.org/10.1002/hup.2870

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically