Design and Evaluation of an In-Vehicle Real-Time Drunk Driving Detection System

NCT ID: NCT05796609

Last Updated: 2023-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-05
• Study Completion Date: 2023-08-01

Brief Summary

To analyze driving behavior of individuals under the influence of alcohol while driving in a real car. Based on the in-vehicle variables, the investigators aim at establishing algorithms capable of discriminating sober and drunk driving using machine learning.

Detailed Description

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. However, autonomous driving (level 4 or 5) is likely to be broadly available only at a substantially later time point than previously thought due to increasing concerns of safety associated with this technology. Therefore, solutions bridging the upcoming time period by more rapidly and directly addressing the problem of drunk driving associated traffic incidents are urgently needed.

On the supposition that driving behavior differs significantly between sober state and drunk state, the investigators assume that different driving patterns of people under alcohol influence compared to sober states can be used to generate drunk driving detection models using machine learning algorithms. In this study, driving for data collection is initially performed at a sober baseline state (no alcohol) and then after alcohol administration (with a target of 0.15 mg/l and 0.35 mg/l breath alcohol concentration).

Conditions

Drunk Driving; Alcohol Drinking; Impaired Driving

Keywords

Driving; Automotive Technology; Car; Alcohol Biomarker; Test Track

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Treatment Group

Driving under the influence of alcohol

Aware of the possible induction of alcohol (purpose of the study), but blinded to the actual amount and target blood alcohol concentration

Group Type: EXPERIMENTAL

Driving under the influence of alcohol

Intervention Type: OTHER

Participants will drive in three different states (sober, drunk above and below the legal limit) on a designated circuit with a real car on a test track accompanied by a driving instructor. After the initial sober driving session, participants are administered pre-mixed alcoholic beverages (e.g., vodka orange). Participants are expected to achieve a target breath alcohol concentration of 0.35 mg/l (legal limit in Switzerland is 0.25 mg/l breath alcohol concentration) before the second driving session starts. Finally, the third driving session starts when the participants' breath alcohol concentration drops to 0.15 mg/l.

Participants will be blinded to their alcohol levels during the study.

Measurements: Heart rate, respiration rate, blood oxygen saturation, skin conductance, skin temperature, accelerometer, eye movement, radar, facial expression, audio recording, vehicle data, in-cabin gas concentration

Reference Group

Driving without the influence of alcohol or placebo

Fully informed

Group Type: NO_INTERVENTION

No interventions assigned to this group

Placebo Group

Driving under the influence of a placebo

Not informed (blinded)

Group Type: PLACEBO_COMPARATOR

Driving under the influence of a placebo

Intervention Type: OTHER

Participants will drive three times at the same intervals as the treatment group on a designated circuit with a real car on a test track accompanied by a driving instructor. After the initial driving session, participants receive placebo beverages (e.g., orange juice with vodka flavor).

Participants are fully blinded.

Measurements: Heart rate, respiration rate, blood oxygen saturation, skin conductance, skin temperature, accelerometer, eye movement, radar, facial expression, audio recording, vehicle data, in-cabin gas concentration

Interventions

Driving under the influence of alcohol

Participants will drive in three different states (sober, drunk above and below the legal limit) on a designated circuit with a real car on a test track accompanied by a driving instructor. After the initial sober driving session, participants are administered pre-mixed alcoholic beverages (e.g., vodka orange). Participants are expected to achieve a target breath alcohol concentration of 0.35 mg/l (legal limit in Switzerland is 0.25 mg/l breath alcohol concentration) before the second driving session starts. Finally, the third driving session starts when the participants' breath alcohol concentration drops to 0.15 mg/l.

Participants will be blinded to their alcohol levels during the study.

Measurements: Heart rate, respiration rate, blood oxygen saturation, skin conductance, skin temperature, accelerometer, eye movement, radar, facial expression, audio recording, vehicle data, in-cabin gas concentration

Intervention Type: OTHER

Driving under the influence of a placebo

Participants will drive three times at the same intervals as the treatment group on a designated circuit with a real car on a test track accompanied by a driving instructor. After the initial driving session, participants receive placebo beverages (e.g., orange juice with vodka flavor).

Participants are fully blinded.

Measurements: Heart rate, respiration rate, blood oxygen saturation, skin conductance, skin temperature, accelerometer, eye movement, radar, facial expression, audio recording, vehicle data, in-cabin gas concentration

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Informed consent as documented by signature.
• In possession of a definite Swiss or EU driving license.
• At least 21 years old
• Active driving in the last 6 months.
• No special equipment needed when driving.
• Drinks alcohol at least occasionally (moderate/social consumption).
• Fluent in (Swiss) German and no speech impairment.

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 the biomarker PEth in capillary blood > 200 ng/mL at first visit.
• Known or suspected drug abuse within 4 weeks before the study (e.g., positive urine drug test at first visit).
• Non-compliance to alcohol abstinence within 24 hours before the study visits.
• 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ETH Zurich

OTHER

Sponsor Role: collaborator

University of St.Gallen

OTHER

Sponsor Role: collaborator

University of Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wolfgang Weinmann, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Bern

Locations

Institut für Rechtsmedizin

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

SNCTP000005396

Identifier Type: REGISTRY

Identifier Source: secondary_id

DRIVE Test Track

Identifier Type: -

Identifier Source: org_study_id