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Trial registered on ANZCTR


Registration number
ACTRN12610000263099
Ethics application status
Approved
Date submitted
25/03/2010
Date registered
31/03/2010
Date last updated
11/07/2012
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 in healthy drivers
Secondary ID [1] 1545 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Effect of sleep restriction on driving performance 257034 0
Effect of high therapeutic Temazepam dose on driving performance 257035 0
Validation of ocular measures of drowsiness 257036 0
Condition category
Condition code
Public Health 257191 257191 0 0
Other public health
Neurological 257192 257192 0 0
Studies of the normal brain and nervous system
Mental Health 257193 257193 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 256207 0
Behaviour
Intervention code [2] 256208 0
Other interventions
Comparator / control treatment
Each participant undergoes all treatments: 1) Single orally administered 20mg dose Temazepam controlled against single orally administered 20mg microcellulose placebo capsule; 2) Restricted sleep (4hrs) controlled against normal sleep (no treatment); 3) Restricted sleep (4hrs) and Single orally administered 20mg dose Temazepam compared to 0.05% and 0.08% BAC; 4) Ocular measure of drowsiness (Optalert) compared to electroecephalogram (EEG) and attentional performance measures.
Control group
Placebo

Outcomes
Primary outcome [1] 258084 0
Simulated driving performance on 60min AusEd driving simulator task - measured by: average steering deviation from participant's median lane position (cm), average speed deviation outside the 60-80km/h speed zone, median reaction time for braking after sudden appearance of trucks, & number of crashes of all types.
Timepoint [1] 258084 0
Once each at: Baseline (no treatment, 30min after placebo capsule administration), 0.05% BAC, 0.08% BAC, 2hrs after Temazepam administration, 9am the day after sleep restriction to 4hrs, & 2.30pm the day after sleep restriction to 4hrs.
Primary outcome [2] 258085 0
Ocular measures of drowsiness (via Optalert system)
Timepoint [2] 258085 0
Assessed during the performance of driving simulation, Psychomotor Vigilance Task (PVT), John's Test of Vigilance (JTV) and Osler (Oxford Sleep Resistance) test.
Primary outcome [3] 258086 0
Number and duration of alpha and theta periods (microsleeps) in EEG
Timepoint [3] 258086 0
Assessed during the performance of driving simulation, PVT, JTV and Osler.
Secondary outcome [1] 263681 0
Performance on the PVT
Timepoint [1] 263681 0
Once each at: Baseline (no treatment, 30min after placebo capsule administration), 0.05% BAC, 0.08% BAC, 2hrs after Temazepam administration, 9am the day after sleep restriction to 4hrs, & 2.30pm the day after sleep restriction to 4hrs.
Secondary outcome [2] 263682 0
Performance on the JTV
Timepoint [2] 263682 0
Once each at: Baseline (no treatment, 30min after placebo capsule administration), 0.05% BAC, 0.08% BAC, 2hrs after Temazepam administration, 9am the day after sleep restriction to 4hrs, & 2.30pm the day after sleep restriction to 4hrs.
Secondary outcome [3] 263683 0
Performance on the Osler
Timepoint [3] 263683 0
At baseline before Temazepam/placebo administration, at 9am the day after sleep restriction to 4hrs, and at 2.30pm the day after sleep restriction to 4hrs.
Secondary outcome [4] 263684 0
Stop driving questionnaire score
Timepoint [4] 263684 0
Assessed after performance of test battery (driving simulation, PVT & JTV) at: Baseline (no treatment, 30min after placebo capsule administration), 0.05% BAC, 0.08% BAC, 2hrs after Temazepam administration, 9am the day after sleep restriction to 4hrs, & 2.30pm the day after sleep restriction to 4hrs.
Secondary outcome [5] 263685 0
Karolinska Sleepiness Scale score
Timepoint [5] 263685 0
Assessed upon arrival for testing in each of the three treatment arms, and after performance of test battery (driving simulation, PVT & JTV) at: Baseline (no treatment, 30min after placebo capsule administration), 0.05% BAC, 0.08% BAC, 2hrs after Temazepam administration, 9am the day after sleep restriction to 4hrs, & 2.30pm the day after sleep restriction to 4hrs.
Secondary outcome [6] 263686 0
Sleepiness symptoms questionnaire score
Timepoint [6] 263686 0
Assessed after performance of test battery (driving simulation, PVT & JTV) at: Baseline (no treatment, 30min after placebo capsule administration), 0.05% BAC, 0.08% BAC, 2hrs after Temazepam administration, 9am the day after sleep restriction to 4hrs, & 2.30pm the day after sleep restriction to 4hrs.

Eligibility
Key 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.
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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256708 0
Government body
Name [1] 256708 0
Vicroads
Country [1] 256708 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Institute for Breathing and Sleep
Address
Austin Hospital
PO Box 5555
Heidelberg, Victoria 3084
Country
Australia
Secondary sponsor category [1] 255995 0
Government body
Name [1] 255995 0
Vicroads
Address [1] 255995 0
60 Denmark Street
Kew, Victoria 3101
Country [1] 255995 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258720 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 258720 0
Ethics committee country [1] 258720 0
Australia
Date submitted for ethics approval [1] 258720 0
Approval date [1] 258720 0
06/01/2009
Ethics approval number [1] 258720 0
H2009/03435

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30981 0
Address 30981 0
Country 30981 0
Phone 30981 0
Fax 30981 0
Email 30981 0
Contact person for public queries
Name 14228 0
Bronwyn Stevens
Address 14228 0
Institute of Breathing and Sleep
Bowen Centre
Dept. Respiratory and Sleep Medicine
Austin Hospital
PO Box 5555
Heidelberg, Victoria 3084
Country 14228 0
Australia
Phone 14228 0
+61 3 9496 3528
Fax 14228 0
Email 14228 0
[email protected]
Contact person for scientific queries
Name 5156 0
Bronwyn Stevens
Address 5156 0
Institute of Breathing and Sleep
Bowen Centre
Dept. Respiratory and Sleep Medicine
Austin Hospital
PO Box 5555
Heidelberg, Victoria 3084
Country 5156 0
Australia
Phone 5156 0
+61 3 9496 3528
Fax 5156 0
Email 5156 0
[email protected]

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
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Documents added automatically
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