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Completed

NCT Number: NCT04980846

Design and Implementation of a Drunk Driving Detection System

To analyse driving behavior of individuals under the influence of alcohol using a validated research driving simulator. Based on the driving variables provided by the simulator the investigators aim at establishing algorithms capable of discriminating sober and drunk driving patterns using machine learning neural networks (deep machine learning classifiers).

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Key information

Conditions

Transportation Accidents Alcohol Drinking Behavior Criminal Behavior Dangerous Behavior Drinking Behavior Driving Under the Influence Drunk Driving Impaired Driving

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bern

Bern, Switzerland

About this study

Driving under the influence of alcohol (or "drunk driving") is one of the most significant causes of traffic accidents. Alcohol consumption impairs neurocognitive and psychomotor function and has been shown to be associated with an increased risk of driving accidents. Automotive technology is highly dynamic, and fully autonomous driving might, in the end, resolve the issue of alcohol impaired accidents. However, autonomous driving (level 4 or 5) is likely to be broadly available only to a substantially later time point than previously thought due to increasing concerns of safety associated with this technology. Therefore, solutions bridging the upcoming period by more rapidly and directly addressing the problem of drunk driving-associated traffic incidents are urgently needed.

On the supposition that driving behaviour differs significantly between sober and drunk states, the investigators assume that different driving patterns in both states can be used to generate drunk driving detection models using machine learning neural networks (deep machine learning classifiers).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent as documented by signature.
  • In possession of a Swiss or EU driving license for at least two years.
  • At least driving 1'000 kilometers per year.
  • No special equipment needed when driving.
  • Drinks alcohol at least occasionally (moderate/social consumption).
  • Fluent in (Swiss) German and no speech impairment.
  • Lives in or near Bern.

Exclusion criteria

  • Health concerns that are incompatible with alcohol consumption.
  • Any potential participant currently taking illegal drugs or medications that interact with alcohol.
  • Women who are pregnant or breast feeding.
  • Intention to become pregnant during the course of the study.
  • Teetotallers (alcohol abstinent persons).
  • Alcohol misuse (excessive alcohol consumption habits/risky drinking behaviour (according to WHO definition) and/or PEth in capillary blood > 210 ng/mL at first visit.
  • Known or suspected non-compliance or drug abuse.
  • Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant.
  • Participation in another study with investigational drug within the 30 days preceding and during the present study.

Treatment and study plan

Driving under the influence of alcohol with a driving simulator

Other

Participants will drive in three different states (sober, drunk above and below the legal limit) on designated circuits using a driving simulator. After the initial sober driving session, participants are administered pre-mixed alcoholic beverages (e.g., vodka orange). Participants are expected to achieve a target BrAC of 0.35 mg/l (legal limit in Switzerland is 0.25 mg/l BrAC) before the second driving session starts. Finally, the third driving session starts when the participants' BrAC drops to 0.15 mg/l. Heart rate, skin conductance, accelerometer, eye movement, radar, facial expression, and speech will be recorded by a smart-watch, an eye-tracker, microphones and an onboard camera, respectively.

Participants will be blinded to their alcohol levels during the study. They will have to rate their symptoms and their performance via questionnaires before and after each driving session. Further, capillary blood and oral fluid samples will be collected.

Primary outcomes

  1. Accuracy of the DRIVE-model: Diagnostic accuracy of the drunk driving warning system (DRIVE) to detect drunk driving (>= 0.25 mg/l breath alcohol concentration (BrAC)) quantified as the area under the receiver operator characteristics curve (AUC ROC).

    Time frame: 480 minutes

    Accuracy of the DRIVE-model will be assessed using driving data recorded in sober and drunk driving states and driving data will be analysed using applied machine learning technology for impaired driving detection.

Secondary outcomes

  1. Change of velocity

    Time frame: 480 minutes

    Change of velocity between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.

  2. Change of steer

    Time frame: 480 minutes

    Change of steer between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.

  3. Change of brake

    Time frame: 480 minutes

    Change of brake between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.

  4. Change of steer torque

    Time frame: 480 minutes

    Change of steer torque between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.

  5. Change of steer speed

    Time frame: 480 minutes

    Change of steer speed between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.

  6. Change of time driving over midline

    Time frame: 480 minutes

    Change of time over midline between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.

  7. Change of swerving

    Time frame: 480 minutes

    Change of swerving between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.

  8. Change of spinning

    Time frame: 480 minutes

    Change of spinning between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.

  9. Change of gaze behavior

    Time frame: 480 minutes

    Change of gaze behavior (as gaze velocity, acceleration or direction changes) between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.

  10. Change of gaze regions of interest

    Time frame: 480 minutes

    Change of gaze regions of interest (as amount and duration of speedometer or front shield inspections) between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.

  11. Change of gaze events

    Time frame: 480 minutes

    Change of gaze events (as amount and duration of fixations or saccades) between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.

  12. Defining the alcohol concentration when driving performance is decreased

    Time frame: 480 minutes

    Breath alcohol concentration (mg/l BrAC) when driving performance begins to be impaired will be assessed based on significantly altered driving parameters for drunk driving above the legal limit (>= 0.25 mg/l BrAC), below the legal limit (<0.25 mg/l BAC) and sober driving.

  13. Driving performance while being sober, above and within the legal limit

    Time frame: 480 minutes

    Based on significantly altered driving parameters above the legal limit of drunk driving (>= 0.25 mg/l breath alcohol concentration in Switzerland) driving performance while being sober, above and within the legal limit will be assessed.

  14. Change of heart-rate

    Time frame: 480 minutes

    Change of heart-rate between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.

  15. Change of heart-rate variability

    Time frame: 480 minutes

    Change of heart-rate variability between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.

  16. Change of wrist accelerometer

    Time frame: 480 minutes

    Change of wrist accelerometer recorded by a wearable between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.

  17. Change of electrodermal activity (EDA)

    Time frame: 480 minutes

    Change of EDA between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.

  18. Change of skin temperature

    Time frame: 480 minutes

    Change of skin temperature between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.

  19. Change of oral fluid cortisol

    Time frame: 2 weeks

    Change of oral fluid cortisol between before the study day, before driving, during driving in sober state, above the legal limit (>= 0.25 mg/l BrAC), and under the legal limit (< 0.25 mg/l BrAC) will be assessed.

  20. Change of phosphatidylethanol (PEth) in capillary blood

    Time frame: 2 weeks

    Change of phosphatidylethanol in capillary blood between before the study day, before driving, during driving in sober state, above the legal limit (>= 0.25 mg/l BrAC), and under the legal limit (< 0.25 mg/l BrAC) will be assessed.

  21. Change of ethylglucuronide (EtG) in capillary blood

    Time frame: 2 weeks

    Change of ethylglucuronide in capillary blood between before the study day, before driving, during driving in sober state, above the legal limit (>= 0.25 mg/l BrAC), and under the legal limit (< 0.25 mg/l BrAC) will be assessed.

  22. Change of ethylsulfate (EtS) in capillary blood

    Time frame: 2 weeks

    Change of ethylsulfate in capillary blood between before the study day, before driving, during driving in sober state, above the legal limit (>= 0.25 mg/l BrAC), and under the legal limit (< 0.25 mg/l BrAC) will be assessed.

  23. Change of cortisol in capillary blood

    Time frame: 2 weeks

    Change of cortisol in capillary blood between before the study day, before driving, during driving in sober state, above the legal limit (>= 0.25 mg/l BrAC), and under the legal limit (< 0.25 mg/l BrAC) will be assessed.

  24. Accuracy-comparison of DRIVE-model and DRIVEplus-model

    Time frame: 480 minutes

    Diagnostic accuracy of the drunk driving warning system (DRIVING) to detect drunk driving (>= 0.25 mg/l BrAC) quantified as the area under the receiver operator characteristics curve (AUC ROC) using only driving parameters (DRIVE-model) will be compared to the DRIVE-model with additional integration of physiological parameters (heart-rate, heart-rate variability, electrodermal activity (EDA), skin temperature, accelerometer, facial expression, gaze behavior, and radar) (DRIVEplus-model)

  25. Diagnostic accuracy in detecting drunk driving (>= 0.25 mg/l BrAC) quantified as the area under the receiver operator characteristics curve using physiological data

    Time frame: 480 minutes

    Accuracy of drunk driving detection using physiological data (heart-rate, heart-rate variability, skin temperature, EDA, accelerometer) recorded with wearable devices during the study period will be analysed using applied machine learning technology.

  26. Diagnostic accuracy in detecting drunk driving (>= 0.25 mg/l BrAC) quantified as the area under the receiver operator curve (AUC-ROC) using video data

    Time frame: 480 minutes

    Using video data recorded by a camera and a thermal camera accuracy in drunk driving detection will be analysed with applied machine learning technology.

  27. Diagnostic accuracy in detecting drunk driving (>= 0.25 mg/l BrAC) quantified as the area under the receiver operator curve (AUC-ROC) using eye-tracking data

    Time frame: 480 minutes

    Using eye-tracking data recorded by a camera and an eye-tracker (to record gaze behaviour) accuracy in drunk driving detection will be analysed with applied machine learning technology.

  28. Diagnostic accuracy in detecting drunk driving (>= 0.25 mg/l BrAC) quantified as the area under the receiver operator curve (AUC-ROC) using audio data

    Time frame: 480 minutes

    Using audio data recorded by microphones accuracy in drunk driving detection will be analysed with applied machine learning technology.

  29. Diagnostic accuracy in detecting drunk driving (>= 0.25 mg/l BrAC) quantified as the area under the receiver operator curve (AUC-ROC) using radar sensor data

    Time frame: 480 minutes

    Using radar sensor data (directed on the body of the driver) accuracy in drunk driving detection will be analysed with applied machine learning technology.

  30. Self-estimation of alcohol concentrations

    Time frame: 480 minutes

    Correlation between self-estimated alcohol concentrations and measured breath alcohol concentrations will be assessed.

  31. Self-estimation of driving performance

    Time frame: 480 minutes

    Correlation between self-estimated driving performance and measured driving performance based on significantly altered driving parameters in sober state, above the legal limit (>= 0.25 mg/l BrAC), and under the legal limit (< 0.25 mg/l BrAC) will be assessed. Driving performance will be assessed with two questionnaires. Driving performance will be assessed with on an absolute 5-point scale from 0-5 (a higher value means higher driving performance).

  32. Self-estimation of workload

    Time frame: 480 minutes

    Correlation between self-estimated workload and measured driving performance based on significantly altered driving parameters in sober state, above the legal limit (>= 0.25 mg/l BrAC), and under the legal limit (< 0.25 mg/l BrAC) will be assessed. Workload will be assessed an absolute 20-point scale from 0-20 (a higher value means higher workload).

  33. Self-estimation of sleepiness levels

    Time frame: 480 minutes

    Correlation between self-estimated sleepiness levels, measured driving performance, and measured breath alcohol concentrations based on significantly altered driving parameters in sober state, above the legal limit (>= 0.25 mg/l BrAC), and under the legal limit (< 0.25 mg/l BrAC) will be assessed. Sleepiness will be assessed on an absolute 7-point scale from 0-6 (a lower value means less sleepiness).

  34. Incidence of Adverse Events (AEs)

    Time frame: 3 weeks

    Adverse Events will be recorded at each study visit.

  35. Incidence of Serious Adverse Events (SAEs)

    Time frame: 3 weeks

    Serious Adverse Events will be recorded at each study visit.

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Collaborators

  • ETH Zurich
  • University of St.Gallen

Registry information

Official study title

Non-randomised, Controlled, Interventional Single-centre Study for the Design and Evaluation of an In-vehicle Drunk Driving Detection System

Acronym: DRIVE

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 28, 2021
Registry last updated
Jan 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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