UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056124 |
|---|---|
| Receipt number | R000064124 |
| Scientific Title | Research on Predicting and Evaluating Unsafe Driving Using Objective Indicators |
| Date of disclosure of the study information | 2024/11/12 |
| Last modified on | 2024/11/12 06:10:23 |
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Basic information
Public title
Establishing objective indicators to predict unsafe driving
Acronym
Unsafe Prediction Indicator Test (UPIT)
Scientific Title
Research on Predicting and Evaluating Unsafe Driving Using Objective Indicators
Scientific Title:Acronym
Unsafe Driving Behavior Study (UDBS)
Region
| Japan |
Condition
Condition
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.
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Japan's population is aging, with people aged 65 and over comprising 29.0% of the total population as of 2022. The proportion of individuals aged 75 and above is also increasing, leading to a growing concern over elderly drivers' involvement in traffic accidents. While the number of fatal accidents caused by drivers aged 75 and above has remained stable, the percentage of such accidents among total fatalities is rising. To address this, revisions to the Road Traffic Law were introduced, aiming to prevent accidents caused by elderly drivers, including the introduction of driving skill tests for drivers, especially those aged 75 and above with prior traffic violations. These measures, while promoting safer driving among older drivers, underscore the need to address declining driving abilities due to dementia and other health concerns. SUBARU, a partner in this research effort, has committed to its "protecting human life" mission, setting a target to eliminate fatal traffic accidents by 2030. This emphasizes the importance of supporting safe driving practices among older drivers. This research aims to develop technology and systems to address cognitive decline in Japan's aging population and preemptively curb dangerous driving behaviors. Specifically, the objective is to establish indices reflecting drivers' internal states, driving operation impacts, and behavior changes under abnormal conditions. The study's ultimate goal is to contribute to traffic accident reduction among elderly drivers within the broader framework of traffic safety measures in an aging society. By focusing on issues such as the rise in dementia and driving impairments due to medication, the research seeks to preemptively prevent dangerous driving incidents, enhancing public safety for society as a whole.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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 secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers
Eligibility criteria:
l Persons of either sex, aged 65 years or older
l Persons holding a valid driving licence
l Persons who have consented to participate in the study
Patients with MCI and SCI
Eligibility criteria:
l Persons of either sex, aged 65 years or older l Persons aged 65 years and over
l Persons holding a valid driving licence
l Persons who agree to participate in the study
Key exclusion 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
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takei |
| Middle name | |
| Last name | Yuichi |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Psychiatry and Neuroscience
Zip code
371-8511
Address
3-39-22 Showa, Maebashi, Gunma 371-8511, Japan
TEL
027-220-8188
tyuichi@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Takei |
| Middle name | |
| Last name | Yuichi |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Psychiatry and Neuroscience
Zip code
371-8511
Address
3-39-22 Showa, Maebashi, Gunma 371-8511, Japan
TEL
027-220-8188
Homepage URL
tyuichi@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital Clinical Research Review Board
Address
3-39-22 Showa, Maebashi, Gunma 371-8511
Tel
027-220-8747
irb-jimukk-ciru@ml.gunma-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2029 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 12 | Day |
Last modified on
| 2024 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064124
