Bordeaux University Hospital
Bordeaux, 33000, France
NCT Number: NCT04188626
At level 3 conditionally automated, the vehicle ensures driving and the driver disengages from driving to perform another activity independent of driving (ex: read a book, play on his phone ....). However, drivers are expected to be available to take over control for the case of system failure or limitation. This take-over control must take place in a limited time, very short, of the order of a few seconds. To take-over control of the vehicle quickly and efficiently, the driver must be, at the time of take-over, vigilant, efficient, and attentive to the environment and focused on the take-over of manual driving. Predicting the driver's reengagement capabilities to ensure that the driver will be able to take-over control of the vehicle is crucial at level 3 of autonomous driving.
The objective of ANTIDOTE is to determine physiological and behavioural parameters capable of predicting the take-over quality in level 3 conditionally automated vehicles in a simulated highway driving situation in healthy drivers or drivers with attention disorders.
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Notify Me20 year–75 year
All sexes
Interventional
Not applicable
Bordeaux, 33000, France
At level 3 conditionally automated, the vehicle ensures driving and the driver disengages from driving to perform non-related driving tasks (ex: read a book, play on his phone ....). However, drivers are expected to be available to take over control for the case of system failure or limitation. This take-over control must take place in a limited time, very short, of the order of a few seconds. To take-over control of the vehicle quickly and efficiently, the driver must be, at the time of take-over, vigilant, efficient, and attentive to the environment and focused on the take-over of manual driving. Predicting the driver's reengagement capabilities to ensure that the driver will be able to take-over control of the vehicle is crucial at level 3 of autonomous driving.
In this context, the objective of ANTIDOTE is to determine physiological and behavioural parameters capable of predicting the take-over quality in level 3 conditionally automated vehicles in a simulated highway driving situation.
This study will examine how engagement will impact take-over control quality in 6 non-driving related secondary tasks. A driving simulator study will be conducted and data from a total of 32 healthy drivers and 16 drivers with attention disorders will be used to evaluate take-over quality.
Electrophysiological (EEG, ECG, EDA, EMG, respiration) and behavioral data will be recorded before, during and after the take-over control.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Common inclusion criteria:
Healthy volunteers specific inclusion criteria:
ADHD patients specific inclusion criteria:
Exclusion criteria
Healthy volunteers specific inclusion criteria:
ADHD patients specific inclusion criteria:
The volunteers will be placed in a driving simulator that will simulate autonomous highway driving. This autonomous driving will be interrupted by take-over requests related to events that disrupt autonomous driving. During autonomous driving, the driver will have to disengage from driving by performing non-related driving tasks. During each non-related driving tasks, a take-over request will be sent. Electrophysiological (EEG, ECG, EDA, EMG, respiration) and behavioural data will be recorded before, during and after the take-over control.
Time frame: 8 secondes after take-over request
Quality of driving take-over behaviour (Good/bad) will be assessed by collision (collision or driving off the road) and critical encounters (Time To Collision).
Time to collision (TTC) refers to the time required for the vehicle to collide with the stationary obstacle obstructing the driving lane if it continues at its speed at the time it changes to the next lane completely.
Good : no collision AND TTC >= 1.5 secondes Bad : collision or no collision AND TTC < 1.5 secondes
Time frame: during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
Physiological parameter: EEG will be recorded and Alpha, theta and gamma activity will be analyzed in the waking EEG.
Time frame: during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
Physiological parameter : ECG recordings and heart rate variability based on time and frequency domain will be analyzed.
Time frame: during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
Physiological parameter : surface EMG will be recorded and Derive Average Rectified, derive Integrated Root and means Square EMG will be analyzed and EMG Frequency & Power Analysis.
Time frame: during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
Physiological parameter : EDA will be recorded and skin conductance level analyzed.
Time frame: during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
Physiological parameter : EDA will be recorded and skin conductance response analyzed.
Time frame: during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
Physiological parameter : Respiratory frequency recorded
Time frame: during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
Physiological parameter : Physical activity expressed in count/min
Time frame: during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
Physiological parameter :Eye tracking will be recorded and point of gaze, Perclos, blinks, diameters of pupils analyzed.
Time frame: 8 secondes after take-over request
Visual analogue scale to assess subjective driving take-over control quality (Subjective scale).
The scale ranges from 0 " bad" to 100 "good"
Time frame: 8 secondes after take-over request
Visual analogue scale to assess subjective level of attention and distraction just before take-over control request The scale ranges from 0 "attentive" to 100 "inattentive"
PSA Automobiles S.A.
Industry
Identification of Physiological and Behavioural Biomarkers to Predict Take-over Control Quality in Level 3 Conditionally Automated Vehicles
Acronym: ANTIDOTE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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