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

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 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


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

Value
https://center6.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