UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030352 |
|---|---|
| Receipt number | R000034656 |
| Scientific Title | The change of palmar sweating response, skin potential reflex, and prefrontal oxyhemoglobin in driving a vehicle |
| Date of disclosure of the study information | 2019/05/31 |
| Last modified on | 2018/04/26 09:18:48 |
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Basic information
Public title
The change of palmar sweating response, skin potential reflex, and prefrontal oxyhemoglobin in driving a vehicle
Acronym
The change of PSR, SPR, and prefrontal oxHB in driving a vehicle
Scientific Title
The change of palmar sweating response, skin potential reflex, and prefrontal oxyhemoglobin in driving a vehicle
Scientific Title:Acronym
The change of PSR, SPR, and prefrontal oxHB in driving a vehicle
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measure the palmar sweating response (PSR), skin potential reflection (SPR), prefrontal cortex Oxy - Hb concentration during driving, and compare it with the response at driving simulation test.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in palmar sweating responses (PSR), skin potential reflex (SPR) and prefrontal cortex Oxy - Hb concentration during driving.
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
Driving a car
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
Person who is driving a car on a daily basis
Key exclusion criteria
Persons who do not have a driver's license
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayoshi Kobayashi |
Organization
School of Health Science, Shinshu University
Division name
Occupational Therapy
Zip code
Address
3-1-1, Asahi, Matsumoto, Nagano Prefecture
TEL
0263-37-2403
mkobaya@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayoshi Kobayashi |
Organization
School of Health Science, Shinshu University
Division name
Occupational Therapy
Zip code
Address
3-1-1, Asahi, Matsumoto, Nagano Prefecture
TEL
0263-37-2403
Homepage URL
mkobaya@shinshu-u.ac.jp
Sponsor or person
Institute
School of Health Science, 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
Address
Tel
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
| 2019 | Year | 05 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 11 | Day |
Last modified on
| 2018 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034656
