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

NCT05796609 | Completed

• 2 other identifiers: DRIVE Test TrackSNCTP000005396
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Drunk Driving; Alcohol Drinking; Impaired Driving

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of the drunk driving warning system (DRIVE) to detect states of alcohol influence while driving quantified as the Area Under the Receiver Operator Characteristics Curve (AUROC)

  The machine learning model is developed and evaluated based on in-vehicle data generated in different states of alcohol intoxication. Detection performance of alcohol influence is quantified as AUROC.

  480 minutes

Secondary Outcomes (30)

• Diagnostic accuracy of the drunk driving warning system using physiological data to detect states of alcohol influence quantified as the Area Under the Receiver Operator Characteristics Curve (AUROC)

  480 minutes

• Diagnostic accuracy of the drunk driving warning system using eye-tracking data to detect states of alcohol influence quantified as the AUROC

  480 minutes

• Diagnostic accuracy of the drunk driving warning system using controller area network data of the study car to detect states of alcohol influence quantified as the AUROC

  480 minutes

• Diagnostic accuracy of the drunk driving warning system using audio data to detect states of alcohol influence quantified as the AUROC

  480 minutes

• Diagnostic accuracy of the drunk driving warning system using radar sensor data to detect states of alcohol influence quantified as the AUROC

  480 minutes

Study Arms (3)

Treatment Group

EXPERIMENTAL

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

Other: Driving under the influence of alcohol

Reference Group

NO INTERVENTION

Driving without the influence of alcohol or placebo Fully informed

Placebo Group

PLACEBO COMPARATOR

Driving under the influence of a placebo Not informed (blinded)

Other: Driving under the influence of a placebo

Interventions

Driving under the influence of alcohol 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

Treatment Group

Driving under the influence of a placebo 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

Placebo Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bern: lead
• ETH Zurich: collaborator
• University of St.Gallen: collaborator

Study Sites (1)

Institut für Rechtsmedizin

Bern, 3008, Switzerland

Location

MeSH Terms

Conditions

Driving Under the Influence; Alcohol Drinking; Carney Complex

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Criminal Behavior; Behavior; Dangerous Behavior; Drinking Behavior; Myxoma; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Heart Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Heart Diseases; Cardiovascular Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Abnormalities

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Wolfgang Weinmann, Prof. Dr.

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants of the treatment group are aware of the possible induction of alcohol (purpose of the study), but blinded to the actual amount and target blood alcohol concentration. The participants of the reference group are fully informed that they do not get alcohol (open-label). The participants of the placebo group are not informed that they do not get alcohol but a placebo (blinded).
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Treatment group (32 participants); Reference group (12 participants); Placebo group (12 participants)

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: April 3, 2023
• Study Start: April 5, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)