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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030352
Receipt No. 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

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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
Email 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
Email mkobaya@shinshu-u.ac.jp

Sponsor
Institute School of Health Science, Shinshu University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034656

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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