- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03893006
Vehicle Automation Impact on Drivers (AUTODRIVE)
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Jordan Navarro, MD
- Telefonní číslo: 00 33 4 78 77 30 52
- E-mail: jordan.navarro@univ-lyon2.fr
Studijní záloha kontaktů
- Jméno: Emanuelle Reynaud, MD
- Telefonní číslo: 00 33 4 78 77 24 31
- E-mail: emanuelle.Reynaud@univ-lyon2.fr
Studijní místa
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Bron, Francie
- Nábor
- Laboratoire d'Etude des Mécanismes Cognitifs (EMC)
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Kontakt:
- Jordan NAVARRO, PhD
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Dílčí vyšetřovatel:
- Perrine SEGUIN, MD
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Vrchní vyšetřovatel:
- Jordan NAVARRO, PhD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: UnAssisted (UA)
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.
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From no automation of the vehicle to full automation through warnings, shared control and partly automated automation levels.
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Experimentální: Assisted (A)
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).
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From no automation of the vehicle to full automation through warnings, shared control and partly automated automation levels.
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Experimentální: Shared Control (SC)
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).
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From no automation of the vehicle to full automation through warnings, shared control and partly automated automation levels.
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Experimentální: Partly Autonomous (PA)
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.
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From no automation of the vehicle to full automation through warnings, shared control and partly automated automation levels.
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Experimentální: Fully Autonomous (FA)
This term refers to a completely automated driving experience.
The on-board technologies take over all the driving tasks for any driving situation.
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From no automation of the vehicle to full automation through warnings, shared control and partly automated automation levels.
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Experimentální: Any Automation (AA)
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.
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From no automation of the vehicle to full automation through warnings, shared control and partly automated automation levels.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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BOLD effect
Časové okno: 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.
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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.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Behavioral changes
Časové okno: 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.
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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. |
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.
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Jordan Navarro, MD, : Laboratoire d'Etude des Mécanismes Cognitifs (EMC) -Université Lumière Lyon 2
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 69HCL19_0141
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