Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
ACTRN12613001119785
Ethics application status
Approved
Date submitted
23/09/2013
Date registered
8/10/2013
Date last updated
8/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Real-time Driver Drowsiness Feedback Improves Driver Alertness and Self-reported Driving Performance
Scientific title
Military drivers receiving infra-red oculography-generated drowsiness feedback, compared with no feedback, experience reduced drowsiness whilst driving and report improved self-rated driving performance.
Secondary ID [1] 283288 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Driver drowsiness 290171 0
Condition category
Condition code
Other 290558 290558 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention was infra-red oculography-generated feedback of drowsiness level. Drivers wore glasses fitted with a device which uses infra-red wavelengths directed at the eyelid to measure eye blink characteristics. The data was used by the system under test to calculate a near real-time score which indicates a person's level of drowsiness. A drowsiness score is generated every 60 seconds. For the intervention, this drowsiness score is presented to the driver via a dashboard mounted numerical LED display. Participants are able to view their drowsiness levels whilst driving via a dashboard-mounted LED display. Drivers had their drowsiness levels recorded whilst driving in a naturalistic setting including sessions of off-duty driving in their own vehicles, commuting to and from work in private vehicles, and duty driving in military vehicles. As such, duration and frequency of driving sessions varied and were neither prescribed nor controlled. It was expected that drivers would complete at least two driving sessions per day for the period of the trial (8 weeks) and be a mixture of private and duty driving. The intervention had two conditions; feedback ON and feedback OFF. Each participant experienced one of the conditions during each of their naturally occurring driving sessions for a period of four weeks. At the end of the four weeks the participant was switched to the other condition for the remaining four weeks. The order of conditions was counterbalanced such that roughly equal numbers of participants were in each condition within a four week period. There was no follow-up period as the intended effects (reduced drowsiness whilst driving, improved driving performance) of the intervention (drowsiness level feedback) were transient phenomena of interest and not ongoing beyond the duration of the intervention. There was no washout period. Participants transitioned from one condition to the other in the space of a few minutes as there were no ongoing effects of being in one condition or the other.
Intervention code [1] 288013 0
Other interventions
Comparator / control treatment
No treatment
Control group
Active

Outcomes
Primary outcome [1] 290581 0
Johns Drowsiness Scale (JDS) score
Timepoint [1] 290581 0
Mean score over duration of each driving session. The mean JDS score per drive was calculated for post analysis purposes using SPSS after the trial had concluded.
Primary outcome [2] 290582 0
Karolinska Sleepiness Scale (KSS) score
Timepoint [2] 290582 0
at end of each driving session
Primary outcome [3] 290583 0
driving performance self-rating
Timepoint [3] 290583 0
at end of each driving session
Secondary outcome [1] 304842 0
Number of JDS peaks. Within a driving session the transition of JDS scores from consecutively increasing scores to a lesser score was defined as a JDS peak and counted using a custom-made computer program. The number of these transitions was summed to form the number of JDS peaks per driving session.
Timepoint [1] 304842 0
The number of JDS peaks were calculated for post analysis purposes after the trial had concluded.
Secondary outcome [2] 304843 0
Average JDS peak duration. Within a drive, the number of consecutive JDS scores at the same level following an increase and preceding a decrease was defined as a JDS peak duration, and calculated using a custom-made computer program. The average of these peak durations per drive was calculated.
Timepoint [2] 304843 0
The average JDS peak duration was calculated for post analysis purposes after the trial had concluded.

Eligibility
Key inclusion criteria
Members of an Australian Army reserve unit
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-drivers and infrequent duty drivers (self-identified).

Study design
Purpose of the study
Prevention
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The number of participants was determined by the number available from the population provided and which met the inclusion and exclusion criteria.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/04/2012
Actual
17/04/2012
Date of last participant enrolment
Anticipated
15/05/2012
Actual
15/05/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 288028 0
Government body
Name [1] 288028 0
Australian Defence Test and Evaluation Office (ADTEO)
Country [1] 288028 0
Australia
Primary sponsor type
Government body
Name
Defence Science and Technology Organisation (DSTO)
Address
Third Avenue
PO Box 1500
Edinburgh, SA, 5111
Country
Australia
Secondary sponsor category [1] 286745 0
None
Name [1] 286745 0
Address [1] 286745 0
Country [1] 286745 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289949 0
DSTO Human Sciences Ethics Committee
Ethics committee address [1] 289949 0
Ethics committee country [1] 289949 0
Australia
Date submitted for ethics approval [1] 289949 0
Approval date [1] 289949 0
22/03/2012
Ethics approval number [1] 289949 0
LOD 14-12

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

Contacts
Principal investigator
Name 43014 0
Dr Eugene Aidman
Address 43014 0
Defence Science and Technology Organisation
Land Division
Third Avenue
PO Box 1500
Edinburgh, SA, 5152
Country 43014 0
Australia
Phone 43014 0
+61 8 7389 6844
Fax 43014 0
Email 43014 0
[email protected]
Contact person for public queries
Name 43015 0
Carolyn Chadunow
Address 43015 0
Defence Science and Technology Organisation
Land Division
Third Avenue
PO Box 1500
Edinburgh, SA, 5152
Country 43015 0
Australia
Phone 43015 0
+61 8 7389 5106
Fax 43015 0
Email 43015 0
[email protected]
Contact person for scientific queries
Name 43016 0
Eugene Aidman
Address 43016 0
Defence Science and Technology Organisation
Land Division
Third Avenue
PO Box 1500
Edinburgh, SA, 5152
Country 43016 0
Australia
Phone 43016 0
+61 8 7389 6844
Fax 43016 0
Email 43016 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.