Establishing objective indicators to predict unsafe driving

UMIN ID: UMIN000056124

Registered date:12/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: The study subjects will be general volunteers with driving licences, andpatientswithmildcognitive impairment (MCI) or subjective cognitive impairment (SCI) who are outpatients at Tsutsuji Mental Hospital.
• Date of first enrollment: 2024/11/30
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): The research subjects are asked to pre-design and drive a course in which the characteristics of spatial comprehension, judgement and attention are significantly expressed. For driving, a vehicle equipped with measurement equipment is used. Vehicle information is measured in terms of speed, braking and steering. At the same time, biometric information (electrocardiogram, heart rate, electroencephalogram, eye movements, blood oxygen saturation, electroencephalogram, skin electrical activity, myoelectric potentials, eye potentials and driving videos of the research subjects) is obtained. For ECG, heart rate, EEG, skin electrical activity, myoelectric potentials and eye potentials, a simple portable device is used. For eye movement measurements, an eye tracker is used. For the driving videos of the research subjects, four charge-coupled device (CCD) cameras are installed on the windscreen, front dashboard and pedal box to capture images of the research subjects. In addition, a CMOS camera capturing RGB and near-infrared (NIR) images is installed on the front dashboard to capture images of the research subject. Heart rate and blood oxygen saturation will be measured by an Apple watch and data will be acquired by an iPhone for future vehicle implementation. At the start of the study, a researcher will be present to confirm the installation of the sensors, but once the procedure has stabilised, the SUBARU research assistant will carry out the installation independently.

Outcome(s)

• Primary Outcome: The main evaluation item for safe driving is the research by Yasuharu Yamamoto et al. (YasuharuYamamoto et al. (2020) Machine Learning Approach to Predict Road Driving Ability of Healthy Elderly, PCN). A test is used to compare the mean values of the main evaluation items for these two groups.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Healthy volunteers Exclusion criteria: l Persons with drug addiction l Persons diagnosed with dementia l Persons deemed unsuitable by the principal investigator for study participation l Persons with hearing loss Patients with MCI and SCI Exclusion criteria: l Persons with drug dependence l Persons diagnosed with dementia l Persons deemed inappropriate by the principal investigator l Persons with hearing loss

Related Information

• Primary Sponsor: Gunma University Graduate School of Medicine
• Source(s) of Monetary Support: None