Healthy SubjectsANTIDOTENCT04188626
Identification of Biomarkers to Predict Driver Take-over Control Quality
A study testing Driving simulator sessions in people with Healthy Subjects and Attention Deficit, run by PSA Automobiles S.A. at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Attention Deficit
- What is being tested?
- Driving simulator sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 9 Dec 2019to 6 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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,
Who cannot join
- 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,
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Subjects, Attention Deficit
- Being tested
- Driving simulator sessions
- Keywords
- Automated driving, Conditional automation, Driver distraction, Driver take-over quality, Biomarkers
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Driving simulator sessionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Driving session | Experimental | The volunteers will be placed in a driving simulator that will simulate autonomous highway driving. Receives: Behavioral: Driving simulator sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 secondes after take-over request
Secondary outcomes (10)
EEG (electroencephalogram)
Physiological parameter: EEG will be recorded and Alpha, theta and gamma activity will be analyzed in the waking EEG.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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"
Measured: 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"
Measured: 8 secondes after take-over request
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start9 Dec 2019
- Primary completion6 Aug 2020
- Study completion6 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Monocentric preliminary study including an experimental driving session in a driving simulator.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- PSA Automobiles S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Bordeaux, University Hospital, Bordeaux
- Responsible party
- Sponsor
- Investigators
- Pierre PHILIP, MDPhD, Principal investigator, Bordeaux University Hospital - Bordeaux University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188626
- Sponsor's protocol ID
- XP THSE BDX SNPSY
- Other IDs
- ID-RCB (ANSM number)
- Acronym
- ANTIDOTE
- Status last verified
- Sep 2020
- First submitted
- 18 Nov 2019
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Physiological and Behavioural Biomarkers to Predict Take-over Control Quality in Level 3 Conditionally Automated Vehicles
- ClinicalTrials.gov ID
- NCT04188626
- Acronym / sponsor ID
- ANTIDOTE / XP THSE BDX SNPSY
- Conditions
- Healthy Subjects, Attention Deficit
- Keywords
- Automated driving, Conditional automation, Driver distraction, Driver take-over quality, Biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- PSA Automobiles S.A.Industry (pharma, biotech, devices)
- Collaborators
- University of Bordeaux, University Hospital, Bordeaux
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 6 Aug 2020 (actual)
- Study completion
- 6 Aug 2020 (actual)
- First posted
- 6 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Monocentric preliminary study including an experimental driving session in a driving simulator.
| Arm | Type | Receives |
|---|---|---|
| Driving session | Experimental | Behavioral: Driving simulator sessionsThe volunteers will be placed in a driving simulator that will simulate autonomous highway driving. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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)
Key exclusion criteria (18 listed)
- Severe life-threatening conditions in the short term,
- Unstable endocrine diseases
- Progressive cardiovascular diseases
- Progressive neurological diseases treated or not,
- Addiction to a substance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Driving simulator sessionsThe 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. | Behavioural | Driving session |
Primary outcome
Quality of driving take-over behaviour
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
10 secondary outcomes
EEG (electroencephalogram)
Time frame: during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
ECG (electrocardiogram)
Time frame: during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
EMG (electromyogram)
Time frame: 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)
Time frame: 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)
Time frame: during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
Respiration
Time frame: during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
Physical activity
Time frame: during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control
Eye tracking
Time frame: 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
Time frame: 8 secondes after take-over request
Subjective level of attention and distraction before take-over control request
Time frame: 8 secondes after take-over request
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre PHILIP, MDPhD principal investigator
Bordeaux University Hospital - Bordeaux University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Driving simulator sessions in people with Healthy Subjects and Attention Deficit, run by PSA Automobiles S.A. at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of driving take-over behaviour (time frame: 8 secondes after take-over request). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2020.