UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036162 |
|---|---|
| Receipt number | R000041194 |
| Scientific Title | Crossover test using development equipment and control equipment |
| Date of disclosure of the study information | 2022/03/31 |
| Last modified on | 2019/03/11 18:55:30 |
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Basic information
Public title
Development study of driving simulation test using automobile driving cognitive behavior evaluation device
Acronym
Development of driving simulation test
Scientific Title
Crossover test using development equipment and control equipment
Scientific Title:Acronym
Comparative test
Region
| Asia(except Japan) |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the validity and identity of the newly developed driving simulation test
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Palmar sweating responses
Key secondary outcomes
Skin potential reflex
Blood flow response in prefrontal cortex
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Implementation of driving simulation test
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who have acquired a driver's license
Key exclusion criteria
Severe vision disorder
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masayoshi |
| Middle name | |
| Last name | Kobayashi |
Organization
Shinshu University School of Medicine
Division name
Health Sciences
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto
TEL
0263-37-2403
mkobaya@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Masayoshi |
| Middle name | |
| Last name | Kobayashi |
Organization
Shinshu University School of Medicine
Division name
Health Sciences
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto
TEL
0263-37-2403
Homepage URL
mkobaya@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University Medical School Medical Ethics Committee
Address
3-1-1, Asahi, Matsumoto
Tel
0263-37-2572
mdrinri@shinshu-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
| 2022 | Year | 03 | Month | 31 | 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
| 2019 | Year | 03 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 11 | Day |
Last modified on
| 2019 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041194
