Identification of Biomarkers to Predict Driver Take-over Control Quality (ANTIDOTE)

Identification of Physiological and Behavioural Biomarkers to Predict Take-over Control Quality in Level 3 Conditionally Automated Vehicles

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects; Attention Deficit
• Intervention / Treatment: Behavioral: Driving simulator sessions

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • Bordeaux university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Common inclusion criteria:

• male or female aged between 20 and 75 years old
• BMI between 18 and 27
• Subject size between 1.50 m and 1.95 m
• Without sleep complains (Item of Basic Nordic Sleep Questionnaire ≤ 3)
• Without excessive daytime sleepiness (Epworth score ≤ 11)
• Non-professional drivers
• Subjects with a driver's license for at least one year
• Subjects driving at least 5000 km per year.
• Having normal visual acuity (correction with lenses accepted) and normal color vision
• Affiliated to a national health service
• Having given written informed consent to participate in the trial.

Healthy volunteers specific inclusion criteria:

• SCL90R score < 60 for anxiety and depression subscales
• MMSE ≥ 30

ADHD patients specific inclusion criteria:

• Patients with an ADHD disorder according to DSM 5,
• Patients agreeing to discontinue psychostimulant treatment 48 hours prior to the experimental session,

Exclusion Criteria:

• Severe life-threatening conditions in the short term,
• Unstable endocrine diseases
• Progressive cardiovascular diseases
• Progressive neurological diseases treated or not,
• Addiction to a substance
• Night and shift-workers who has taken a constraints in the last 72 hours,
• Psychotropic medication taking
• Benzodiazepine or Z-drug medication taking
• Cardiotropic medication taking
• Volunteers who need glasses to drive
• Having simulator-sickness during the first practice session

Healthy volunteers specific inclusion criteria:

• Psychiatric co-morbidities: current major depressive episode, current hypomanic or manic episode, psychotic disorders, autism spectrum disorder
• Exceeded consumption of coffee, tea or caffeinated drinks(> 5 cups / day)
• Exceeded consumption of alcohol drinks (> 2 drinks / day during the last 6 months)

ADHD patients specific inclusion criteria:

• Psychiatric co-morbidities: current major depressive episode, current hypomanic or manic episode, psychotic disorders, autism spectrum disorder (except ADHD)
• Exceeded consumption of alcohol drinks(> 3 drinks / day during the last 6 months)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Driving session; The volunteers will be placed in a driving simulator that will simulate autonomous highway driving.

Behavioral: Driving simulator sessions; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of driving take-over behaviour	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	8 secondes after take-over request

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG (electroencephalogram)	Physiological parameter: EEG will be recorded and Alpha, theta and gamma activity will be analyzed in the waking EEG.	during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
ECG (electrocardiogram)	Physiological parameter : ECG recordings and heart rate variability based on time and frequency domain will be analyzed.	during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
EMG (electromyogram)	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.	during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
Electrodermal activity 1 (EDA)	Physiological parameter : EDA will be recorded and skin conductance level analyzed.	during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
Electrodermal activity 2 (EDA)	Physiological parameter : EDA will be recorded and skin conductance response analyzed.	during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
Respiration	Physiological parameter : Respiratory frequency recorded	during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
Physical activity	Physiological parameter : Physical activity expressed in count/min	during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
Eye tracking	Physiological parameter :Eye tracking will be recorded and point of gaze, Perclos, blinks, diameters of pupils analyzed.	during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
Subjective driving take-over control quality: Visual analogic scale	Visual analogue scale to assess subjective driving take-over control quality (Subjective scale). The scale ranges from 0 " bad" to 100 "good"	8 secondes after take-over request
Subjective level of attention and distraction before take-over control 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"	8 secondes after take-over request

Collaborators and Investigators

• Sponsor: PSA Automobiles S.A.
• Collaborators: University of Bordeaux; University Hospital, Bordeaux
• Investigators: Principal Investigator: Pierre PHILIP, MDPhD, Bordeaux University Hospital - Bordeaux University

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2019
• Primary Completion (Actual): August 6, 2020
• Study Completion (Actual): August 6, 2020

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 6, 2019

Study Record Updates

• Last Update Posted (Actual): September 21, 2020
• Last Update Submitted That Met QC Criteria: September 18, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Biomarkers; Automated driving; Conditional automation; Driver distraction; Driver take-over quality
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: XP THSE BDX SNPSY; ID-RCB (ANSM number) (Other Identifier: 2019-A01524-53)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Patient could request investigator or Data Protection Officer an access to IPD according to French regulation (act No. 78-17 of 6 January 1978 on data processing, data files and individual liberties, amended by act No. 2004-801 of 6 August 2004) and he EU General Data Protection Regulation (GDPR) of 27 april 2016 applicable since 25 May 2018.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No