Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
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). |
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. |
480 minutes |
|
Secondary |
Change of velocity |
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. |
480 minutes |
|
Secondary |
Change of steer |
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. |
480 minutes |
|
Secondary |
Change of brake |
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. |
480 minutes |
|
Secondary |
Change of steer torque |
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. |
480 minutes |
|
Secondary |
Change of steer speed |
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. |
480 minutes |
|
Secondary |
Change of time driving over midline |
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. |
480 minutes |
|
Secondary |
Change of swerving |
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. |
480 minutes |
|
Secondary |
Change of spinning |
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. |
480 minutes |
|
Secondary |
Change of gaze behavior |
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. |
480 minutes |
|
Secondary |
Change of gaze regions of interest |
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. |
480 minutes |
|
Secondary |
Change of gaze events |
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. |
480 minutes |
|
Secondary |
Defining the alcohol concentration when driving performance is decreased |
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. |
480 minutes |
|
Secondary |
Driving performance while being sober, above and within the legal limit |
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. |
480 minutes |
|
Secondary |
Change of heart-rate |
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. |
480 minutes |
|
Secondary |
Change of heart-rate variability |
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. |
480 minutes |
|
Secondary |
Change of wrist accelerometer |
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. |
480 minutes |
|
Secondary |
Change of electrodermal activity (EDA) |
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. |
480 minutes |
|
Secondary |
Change of skin temperature |
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. |
480 minutes |
|
Secondary |
Change of oral fluid cortisol |
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. |
2 weeks |
|
Secondary |
Change of phosphatidylethanol (PEth) in capillary blood |
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. |
2 weeks |
|
Secondary |
Change of ethylglucuronide (EtG) in capillary blood |
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. |
2 weeks |
|
Secondary |
Change of ethylsulfate (EtS) in capillary blood |
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. |
2 weeks |
|
Secondary |
Change of cortisol in capillary blood |
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. |
2 weeks |
|
Secondary |
Accuracy-comparison of DRIVE-model and DRIVEplus-model |
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) |
480 minutes |
|
Secondary |
Diagnostic accuracy in detecting drunk driving (>= 0.25 mg/l BrAC) quantified as the area under the receiver operator characteristics curve using physiological data |
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. |
480 minutes |
|
Secondary |
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 |
Using video data recorded by a camera and a thermal camera accuracy in drunk driving detection will be analysed with applied machine learning technology. |
480 minutes |
|
Secondary |
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 |
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. |
480 minutes |
|
Secondary |
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 |
Using audio data recorded by microphones accuracy in drunk driving detection will be analysed with applied machine learning technology. |
480 minutes |
|
Secondary |
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 |
Using radar sensor data (directed on the body of the driver) accuracy in drunk driving detection will be analysed with applied machine learning technology. |
480 minutes |
|
Secondary |
Self-estimation of alcohol concentrations |
Correlation between self-estimated alcohol concentrations and measured breath alcohol concentrations will be assessed. |
480 minutes |
|
Secondary |
Self-estimation of driving performance |
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). |
480 minutes |
|
Secondary |
Self-estimation of workload |
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). |
480 minutes |
|
Secondary |
Self-estimation of sleepiness levels |
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). |
480 minutes |
|
Secondary |
Incidence of Adverse Events (AEs) |
Adverse Events will be recorded at each study visit. |
3 weeks |
|
Secondary |
Incidence of Serious Adverse Events (SAEs) |
Serious Adverse Events will be recorded at each study visit. |
3 weeks |
|