BehaviorsAUTODRIVENCT03893006
Vehicle Automation Impact on Drivers
A study of Behaviors and Driving, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Behaviors, Driving, Automation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 8 Oct 2019to 8 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Laboratoire d'Etude des Mécanismes Cognitifs (EMC)
Bron
Jordan NAVARRO, PhD
Perrine SEGUIN, MD
About this study
Official title: On the Highway to Autonomous Driving: How is Automation Changing Humans: Investigations of Drivers' Behaviors, Representations and Neural Processes
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.
- Conditions
- Behaviors, Driving, Automation, Neuroimaging
- Being tested
- Level of vehicle automation
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Level of vehicle automationDevice
From no automation of the vehicle to full automation through warnings, shared control and partly automated automation levels.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Level of vehicle automation |
| Assisted (A) | Experimental | This term refers to driving with warning technology which upon activation sounds an a warning when the vehicle is too close to the edge of the road (off-road warning , Navarro, Mars, \& Hoc, 2007; Suzuki \& Jansson, 2003) or too close to the vehicle in front of it (anti-collision warning; Lee, McGehee, Brown, \& Reyes, 2002). Receives: Device: Level of vehicle automation |
| Shared Control (SC) | Experimental | This term refers to shared tactical control between the driver and the automated assistive technology, both working simultaneously on the physical trajectory of the vehicle, laterally (Griffiths \& Gillespie, 2005; Mulder, Abbink, \& Boer, 2012) as well as longitudinal (Adell, Várhelyi, \& Hjälmdahl, 2008). Receives: Device: Level of vehicle automation |
| Partly Autonomous (PA) | Experimental | This term refers to a situation where the lateral and longitudinal control of the driving are delegated to the automated assistive technology. It consists of a level of automatisation that today is possible to put into application and which often is referred to by the name "Highly Automated Driving" (Navarro, 2018). In this case, the driver is no longer the one who physically ensures the lateral and longitudinal control of the vehicle, but instead supervises the actions of the automated assistive technology. Receives: Device: Level of vehicle automation |
| Fully Autonomous (FA) | Experimental | This term refers to a completely automated driving experience. The on-board technologies take over all the driving tasks for any driving situation. Receives: Device: Level of vehicle automation |
| Any Automation (AA) | Experimental | This term refers to a situation where the drivers can choose the automation device of their choice among the five types presented above and can change it whenever they think it is good to do so. Receives: Device: Level of vehicle automation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Participants will be asked to drive through a variety of driving situations in a driving simulator simulated environment equipped with an eye-tracker. The measure collected will be drivers' behaviors on the steering wheel and pedals as well as their visual behaviors.
The outcome will be a change in the number of actions on the steering wheel (a), pedals (b) and gaze dispersion (c) on the visual scene across the time points.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start8 Oct 2019
- Primary completion8 Jul 2023 (estimated)
- Study completion8 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BehaviorsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jordan Navarro, MD, Principal investigator, : Laboratoire d'Etude des Mécanismes Cognitifs (EMC) -Université Lumière Lyon 2
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893006
- Sponsor's protocol ID
- 69HCL19_0141
- Acronym
- AUTODRIVE
- Status last verified
- Jul 2021
- First submitted
- 8 Mar 2019
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On the Highway to Autonomous Driving: How is Automation Changing Humans: Investigations of Drivers' Behaviors, Representations and Neural Processes
- ClinicalTrials.gov ID
- NCT03893006
- Acronym / sponsor ID
- AUTODRIVE / 69HCL19_0141
- Conditions
- Behaviors, Driving, Automation, Neuroimaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 8 Jul 2023 (estimated)
- Study completion
- 8 Jul 2023 (estimated)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| UnAssisted (UA) | Experimental | Device: Level of vehicle automationThis 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. |
| Assisted (A) | Experimental | Device: Level of vehicle automationThis term refers to driving with warning technology which upon activation sounds an a warning when the vehicle is too close to the edge of the road (off-road warning , Navarro, Mars, \& Hoc, 2007; Suzuki \& Jansson, 2003) or too close to the vehicle in front of it (anti-collision warning; Lee, McGehee, Brown, \& Reyes, 2002). |
| Shared Control (SC) | Experimental | Device: Level of vehicle automationThis term refers to shared tactical control between the driver and the automated assistive technology, both working simultaneously on the physical trajectory of the vehicle, laterally (Griffiths \& Gillespie, 2005; Mulder, Abbink, \& Boer, 2012) as well as longitudinal (Adell, Várhelyi, \& Hjälmdahl, 2008). |
| Partly Autonomous (PA) | Experimental | Device: Level of vehicle automationThis term refers to a situation where the lateral and longitudinal control of the driving are delegated to the automated assistive technology. It consists of a level of automatisation that today is possible to put into application and which often is referred to by the name "Highly Automated Driving" (Navarro, 2018). In this case, the driver is no longer the one who physically ensures the lateral and longitudinal control of the vehicle, but instead supervises the actions of the automated assistive technology. |
| Fully Autonomous (FA) | Experimental | Device: Level of vehicle automationThis term refers to a completely automated driving experience. The on-board technologies take over all the driving tasks for any driving situation. |
| Any Automation (AA) | Experimental | Device: Level of vehicle automationThis term refers to a situation where the drivers can choose the automation device of their choice among the five types presented above and can change it whenever they think it is good to do so. |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Level of vehicle automationFrom no automation of the vehicle to full automation through warnings, shared control and partly automated automation levels. | Device | Any Automation (AA), Assisted (A), Fully Autonomous (FA), Partly Autonomous (PA), Shared Control (SC), UnAssisted (UA) |
Primary outcome
BOLD effect
Time frame: 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.
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.
1 secondary outcome
Behavioral changes
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan Navarro, MD principal investigator
: Laboratoire d'Etude des Mécanismes Cognitifs (EMC) -Université Lumière Lyon 2
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Behaviors and Driving, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jordan Navarro, MD (00 33 4 78 77 30 52, jordan.navarro@univ-lyon2.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD effect (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.