Clinical trial NCT04188626: Identification of Biomarkers to Predict Driver Take-over Control Quality
Official title: Identification of Physiological and Behavioural Biomarkers to Predict Take-over Control Quality in Level 3 Conditionally Automated Vehicles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Attention Deficit
Keywords: Automated driving
Conditional automation
Driver distraction
Driver take-over quality
Biomarkers
Lead sponsor: PSA Automobiles S.A.
Sponsor class: INDUSTRY
Collaborators: name: University of Bordeaux
name: University Hospital, Bordeaux
First posted: 2019-12-06
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Monocentric preliminary study including an experimental driving session in a driving simulator.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Quality of driving take-over behaviour
timeFrame: 8 secondes after take-over request
Secondary outcomes:
measure: EEG (electroencephalogram)
timeFrame: during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
measure: ECG (electrocardiogram)
timeFrame: during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
measure: EMG (electromyogram)
timeFrame: during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
measure: Electrodermal activity 1 (EDA)
timeFrame: during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
measure: Electrodermal activity 2 (EDA)
timeFrame: during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
measure: Respiration
timeFrame: during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
measure: Physical activity
timeFrame: during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
measure: Eye tracking
timeFrame: during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
measure: Subjective driving take-over control quality: Visual analogic scale
timeFrame: 8 secondes after take-over request
measure: Subjective level of attention and distraction before take-over control request
timeFrame: 8 secondes after take-over request
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Bordeaux University Hospital
Study officials:
affiliation: Bordeaux University Hospital - Bordeaux University
name: Pierre PHILIP, MDPhD
role: PRINCIPAL_INVESTIGATOR
References: