Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000344695
Ethics application status
Approved
Date submitted
7/09/2005
Date registered
9/09/2005
Date last updated
9/09/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of Sleep Disorders on motor vehicle accidents
Scientific title
The impact of Sleep Disorders on motor vehicle accidents
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep disorders 438 0
Condition category
Condition code
Neurological 510 510 0 0
Other neurological disorders
Injuries and Accidents 511 511 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
None - crosssectional observational study.
Intervention code [1] 400 0
Lifestyle
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 580 0
To study the prevalence of sleep disorders in patients admitted to a trauma unit as a result of a motor vehicle accident and to compare this to a control group of drivers who have not had a motor vehicle accident.
Timepoint [1] 580 0
Secondary outcome [1] 1236 0
To assess whether those patients in whom a sleep disorder is identifed have increased injury severity and length of stay compared to patients where there is no evidnece of sleep disorder.
Timepoint [1] 1236 0

Eligibility
Key inclusion criteria
Admitted as result of motor vehicle accident.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Passengers will be excluded.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/09/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 571 0
Government body
Name [1] 571 0
Vicroads
Country [1] 571 0
Australia
Primary sponsor type
Individual
Name
A/Prof Matthew Naughton
Address
Country
Secondary sponsor category [1] 463 0
Individual
Name [1] 463 0
Dr Fionnuala Crummy
Address [1] 463 0
Country [1] 463 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1593 0
the Alfred Ethics Committe
Ethics committee address [1] 1593 0
Ethics committee country [1] 1593 0
Australia
Date submitted for ethics approval [1] 1593 0
Approval date [1] 1593 0
Ethics approval number [1] 1593 0

Summary
Brief summary
To ascertain the prevalence of sleep disorders in drivers admitted to hsopital as a result of a motor vehicle accident.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35448 0
Address 35448 0
Country 35448 0
Phone 35448 0
Fax 35448 0
Email 35448 0
Contact person for public queries
Name 9589 0
A/Prof Matthew Naughton
Address 9589 0
Department of Allergy, Immunology and Respiratory Medicine (AIRMED)
The Alfred Hospital
Commercial Road
Prahran Melbourne VIC 3205
Country 9589 0
Australia
Phone 9589 0
+61 3 92763770
Fax 9589 0
Email 9589 0
[email protected]
Contact person for scientific queries
Name 517 0
Dr Fionnuala Crummy
Address 517 0
Department of Allergy Immunology and Respiratory Medicine (AIRMED)
The Alfred Hospital
Commercial Road
Prahran Melbourne VIC 3205
Country 517 0
Australia
Phone 517 0
+61 3 92763770
Fax 517 0
Email 517 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.