UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049171 |
|---|---|
| Receipt number | R000056008 |
| Scientific Title | Influence of Visibility of Hazardous Objects on Palmar Sweat Reaction during Simulated Automobile Driving |
| Date of disclosure of the study information | 2022/10/10 |
| Last modified on | 2024/04/11 09:13:33 |
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Basic information
Public title
Influence of Visibility of Hazardous Objects on Palmar Sweat Reaction during Simulated Automobile Driving
Acronym
Influence of Visibility of Hazardous Objects on Palmar Sweat Reaction during Simulated Automobile Driving
Scientific Title
Influence of Visibility of Hazardous Objects on Palmar Sweat Reaction during Simulated Automobile Driving
Scientific Title:Acronym
Influence of Visibility of Hazardous Objects on Palmar Sweat Reaction during Simulated Automobile Driving
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Rehabilitation medicine | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will conduct a simulated driving test with eye tracking to investigate the effects of visibility of hazardous objects on PSR, SPR, prefrontal cortex oxyHb, and driving maneuvers.
Basic objectives2
Others
Basic objectives -Others
Confirmation of biological response
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Palmar sweating reaction in hazardous and anticipatory situations
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Persons who are 18 years of age or older at the time of consent
A person who has obtained a driver's license for a motor vehicle
Key exclusion criteria
Persons with severe visual impairment
Persons with peripheral neuropathy or skin diseases that affect sweating function
Persons taking drugs that cause drowsiness
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Sagari |
Organization
Shinshu University
Division name
Division of Occupational Therapy School of Health Science
Zip code
3900821
Address
3-1-1 asahi matsumoto nagano japan
TEL
0263372404
sagaria@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Sagari |
Organization
Shinshu University
Division name
Division of Occupational Therapy School of Health Science
Zip code
3900821
Address
3-1-1 asahi matsumoto nagano japan
TEL
0263372404
Homepage URL
sagaria@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and
Technology
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 School of Medicine Ethics Review Board
Address
3-1-1 Asahi, Matsumoto, Nagano 390-8621 JAPAN
Tel
0263372572
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 | 10 | Month | 10 | 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
Completed
Date of protocol fixation
| 2022 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will conduct a simulated driving test with eye tracking to examine the effects of visibility of a hazardous object on PSR, SPR, prefrontal cortex oxyHb, and driving maneuvers. The primary endpoint was palm sweating response in hazardous and anticipatory situations. In addition, the J-SDSA (Stroke Driver's Screening Assessment Japanese Version) will be checked for pass/fail.
Management information
Registered date
| 2022 | Year | 10 | Month | 10 | Day |
Last modified on
| 2024 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056008
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
