UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056737 |
|---|---|
| Receipt number | R000064810 |
| Scientific Title | Development and empirical research of cognitive function evaluation method using eye tracking during driving behavior and intervention method to maintain and improve cognitive function |
| Date of disclosure of the study information | 2025/01/17 |
| Last modified on | 2025/01/16 21:37:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Test on cognitive function evaluation based on eye movements during driving behavior using a drive simulator
Acronym
Test on cognitive function evaluation using drive simulator
Scientific Title
Development and empirical research of cognitive function evaluation method using eye tracking during driving behavior and intervention method to maintain and improve cognitive function
Scientific Title:Acronym
Cognitive function evaluation using eye tracking during driving behavior
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aiming to reduce traffic accidents caused by decline in cognitive function, to develop a new method for evaluating cognitive function using gaze data obtained from line-of-sight detection while driving, as well as methods for maintaining and improving cognitive function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the differences in eye movements during driving behavior between dementia patients and healthy people
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
<Patient group>
The study included inpatients or outpatients of the Department of Geriatrics and Hypertension at Osaka University Hospital, who were diagnosed with or suspected of having dementia, and who met the following eligibility criteria and did not violate any of the exclusion criteria.
<Eligibility criteria>
Persons who are 40 years of age or older at the time of obtaining consent
Persons who have given written consent to participate in the research
<Healthy group>
Among the relatives who visited the hospital with the patient, those who meet the following eligibility criteria and do not violate the exclusion criteria will be targeted.
<Eligibility criteria>
Persons who are 20 years of age or older at the time of obtaining consent
Persons who have given written consent to participate in the research
Key exclusion criteria
Persons whose physical functions have significantly decreased
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Shigeyuki |
| Middle name | |
| Last name | Suzuki |
Organization
Toyoda Gosei Co., Ltd.
Division name
Mobility Development Dept.
Zip code
492-8540
Address
30 Nishinomachi, Kitajima, Inazawa, Aichi
TEL
0587-36-6106
shigeyuki.suzuki@toyoda-gosei.co.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Ito |
Organization
Toyoda Gosei Co., Ltd.
Division name
Mobility Development Dept.
Zip code
492-8540
Address
30 Nishinomachi, Kitajima, Inazawa, Aichi
TEL
0587-36-6106
Homepage URL
takahiro.ito@toyoda-gosei.co.jp
Sponsor or person
Institute
Toyoda Gosei Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Toyoda Gosei Co., Ltd.
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
Ethical Review Board Osaka University Hospital
Address
4th floor, Advanced Medical Innovation Center Building, 2-2 Yamadaoka, Suita-City, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-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
| 2025 | Year | 01 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-
Management information
Registered date
| 2025 | Year | 01 | Month | 16 | Day |
Last modified on
| 2025 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064810
