Brief Summary

In the context of ever-increasing automation in surface vehicles, automation impact on drivers will be investigated through three complementary research axes undertaken under simulated driving: Axe 1 (Cognitive ergonomics), how automation is impacting driving behaviors and visual explorations? Axe 2 (Experimental psychology), how automation is impacting drivers' mental representations of their own driving abilities? Axe 3 (Neuroimaging), how automation is modifying the car driving neural network? And what are drivers' mental representations neural bases? The project tackle both applied and basic research issues using an original experimental neuro ergonomics approach. AUTODRIVE will bring original data on human-machine cooperation, mental representations, cognitive control and brain processes depending on the characteristics of the automation used over a significant period of time (six weeks) on a large sample (N=120) of experienced and inexperienced drivers.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

120

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.8 years study duration

First Submitted

Initial submission to the registry

March 8, 2019

Completed

19 days until next milestone

First Posted

Study publicly available on registry

March 27, 2019

Completed

7 months until next milestone

Study Start

First participant enrolled

October 8, 2019

Completed

3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2023

Completed

Last Updated

July 13, 2021

Status Verified

July 1, 2021

Enrollment Period

3.8 years

First QC Date

March 8, 2019

Last Update Submit

July 12, 2021

Conditions

Behaviors Driving Automation Neuroimaging

Outcome Measures

Primary Outcomes (1)

BOLD effect
Functional magnetic resonance imaging measures brain activity by detecting changes associated with blood flow This technique relies on the fact that cerebral blood flow and neuronal activation are coupled. When an area of the brain is in use, blood flow to that region also increases. The primary form of fMRI uses the blood-oxygen-level dependent (BOLD) contrast in response to an experimental condition (Ogawa, Lee, Kay, \& Tank, 1990), allowing researchers to track changes in oxygen consumption on the brain, and therefore brain activity. BOLD effect is computed by assessing the different relaxation times (T1 and T2) in the brain, as T1 and T2 are different in function of regional cerebral blood flows. The outcome will be a change between mean BOLD effect oven session 1 versus session 2 versus session 3.
Repetition Time (TR) :every 3 seconds, during the 3 fMRI sessions of respectively 1 hour, 0,75 hour and 0,75 hour. fMRI session 2 occurs 3 weeks after fMRI session 1 and 3 weeks before fMRI session 3.

Secondary Outcomes (1)

Behavioral changes
Two experimental sessions of an hour, one before and one after the six weeks of automated driving. Plus six driving sessions of 0,5 hour, one driving session the first day of each experimental week.

Study Arms (6)

UnAssisted (UA)

EXPERIMENTAL

This term refers to driving a vehicle manually without any vehicle automation technology. It will serve as a baseline concerning behaviors, representations and neural results associated with unassisted automobile driving.