Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000730606
Ethics application status
Approved
Date submitted
8/09/2005
Date registered
11/11/2005
Date last updated
10/06/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of sleep deprivation and dexamphetamine on driving, neuropsychological function and brain activity in professional drivers
Scientific title
The effects of sleep deprivation and dexamphetamine on driving, neuropsychological function and brain activity in professional drivers
Secondary ID [1] 286888 0
nil known
Universal Trial Number (UTN)
Trial acronym
SPEED SLEEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep deprivation 882 0
Condition category
Condition code
Neurological 950 950 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A group of current amphetamine users will undergo 4 sessions, 2 sleep deprived and 2 at rest, each with a placebo and dexamphetamine condition.
A group of non-users will undergo 2 sessions, 1 sleep deprived and 1 at rest.
Intervention code [1] 412 0
Behaviour
Comparator / control treatment
no sleep deprivation
placebo (cellulose capsules)
Control group
Placebo

Outcomes
Primary outcome [1] 1248 0
lane deviation on a simulated driving task
Timepoint [1] 1248 0
Users group: primary outcome measures are assessed at rest, following 27-h sleep deprivation, dexamphetamine administration, and following sleep deprivation and dexamphetamine admin.
Non-users group: measures are assessed at rest and following 27-h sleep deprivation.
Secondary outcome [1] 2270 0
Driving simulation
Timepoint [1] 2270 0
27-hours of sleep derpviation
Secondary outcome [2] 2271 0
Psychomotor vigilance task
Timepoint [2] 2271 0
27-hours of sleep derpviation
Secondary outcome [3] 2272 0
PERCLOS - slow eye closure
Timepoint [3] 2272 0
27-hours of sleep derpviation

Eligibility
Key inclusion criteria
(Control group): Curent drivers license. Not used amphetamine within last 10 years. (Users group): Current drivers license. Currently use amphetamine.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of cardiovascular disease, hypertension, epilepsy, diabetes, psychiatric illness; heavy Smokers; 5 or more caffienated beverages per day; Visual impairment that does not correct with glasses; English not first language.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
randomised codes, concealed until completion of the study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised, dexamphetamine not administered to drug-naive group
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2004
Actual
1/06/2004
Date of last participant enrolment
Anticipated
Actual
22/06/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1047 0
Other
Name [1] 1047 0
Institute for Breathing and Sleep
Country [1] 1047 0
Australia
Funding source category [2] 1048 0
Charities/Societies/Foundations
Name [2] 1048 0
Austin Health Medical Research Fund
Country [2] 1048 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
IBAS
Address
Austin Health
Studley Rd
Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 909 0
Charities/Societies/Foundations
Name [1] 909 0
AHMRF
Address [1] 909 0
Austin Health
Studley Rd
Heidelberg VIC 3084
Country [1] 909 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2348 0
Swinburne University
Ethics committee address [1] 2348 0
Ethics committee country [1] 2348 0
Australia
Date submitted for ethics approval [1] 2348 0
Approval date [1] 2348 0
26/03/2004
Ethics approval number [1] 2348 0
Ethics committee name [2] 2349 0
Austin Health
Ethics committee address [2] 2349 0
Ethics committee country [2] 2349 0
Australia
Date submitted for ethics approval [2] 2349 0
Approval date [2] 2349 0
Ethics approval number [2] 2349 0

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

Contacts
Principal investigator
Name 36373 0
Dr Melinda Jackson
Address 36373 0
Institute for Breathing and Sleep
Austin Health
Studley Rd
Heidelberg VIC 3084
Country 36373 0
Australia
Phone 36373 0
+61390356129
Fax 36373 0
Email 36373 0
melinda.jackson@austin.org.au
Contact person for public queries
Name 9601 0
Melinda Jackson
Address 9601 0
Institute for Breathing and Sleep
Austin Health
Studley Rd
Heidelberg VIC 3084
Country 9601 0
Australia
Phone 9601 0
+61 3 94963977
Fax 9601 0
+61 3 94963875
Email 9601 0
melinda.jackson@austin.org.au
Contact person for scientific queries
Name 529 0
Melinda Jackson
Address 529 0
Immunology B Ambulatory Care (IBAS)Austin Health
Bowen Centre
Studley Rd
Heidelberg VIC 3084
Country 529 0
Australia
Phone 529 0
+61 3 94963977
Fax 529 0
Email 529 0
melinda.jackson@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
No additional documents have been identified.