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Healthy Subjects
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Identification of Biomarkers to Predict Driver Take-over Control Quality

Sponsored by PSA Automobiles S.A.

About this trial

Last updated 5 years ago

Study ID

XP THSE BDX SNPSY

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
20 to 75 Years
All
All

Trial Timing

Ended 5 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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,

No

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)

Locations

Location

Status