Clinical trial NCT03893006: Vehicle Automation Impact on Drivers
Official title: On the Highway to Autonomous Driving: How is Automation Changing Humans: Investigations of Drivers' Behaviors, Representations and Neural Processes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Behaviors
Driving
Automation
Neuroimaging
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 120
Sex: ALL
Minimum age (years): 22
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

* To be between the ages of 22 and 45 years old
* Having given an informed consent for the study
* Being registered with the French Social Security System
* No driving license for 60 participants
* Driving license for 4 years or more for 60 participants

Exclusion Criteria:

* No signature on the consent form
* Inability to read or write French.
* Neurologic or psychiatric illness, known or revealed during the inclusion visit
* Substance intake ( taking psychoactive medications or recreational drugs) on the day of the experiment
* Noise intolerance
* Need of vision glasses to drive
* Persons under curators or deprived of civil rights or deprived of their freedom
* Unable to fill a questionnaire (severe cognitive troubles)
* Subjects must not have metallic or electronic implants in the body : pacemakers or pacemaker wires, open heart surgery, artificial heart valve, brain aneurysm surgery, middle ear implant, hearing aid, braces or extensive dental work, cataract surgery or lens implant, implanted mechanical or electrical device, or artificial limb or joint o foreign metallic objects in the body (bullets, BBs, pellets, shrapnel, or metalwork fragments) or current or past employment as machinists, welders or metal workers, tattoos near the head or neck regions, permanent makeup
* Claustrophobia

Primary outcomes:
measure: BOLD effect
timeFrame: 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:
measure: Behavioral changes
timeFrame: 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.
Other outcomes:
Locations:
city: Bron
country: France
facility: Laboratoire d'Etude des Mécanismes Cognitifs (EMC)
Study officials:
affiliation: : Laboratoire d'Etude des Mécanismes Cognitifs (EMC) -Université Lumière Lyon 2
name: Jordan Navarro, MD
role: PRINCIPAL_INVESTIGATOR
References: