UMIN-CTR Clinical Trial

Basic information
Public title	Study of stress measurement by driving simulator
Acronym	Study of stress measurement by driving simulator
Scientific Title	Study of stress measurement by driving simulator
Scientific Title:Acronym	Study of stress measurement by driving simulator
Region	Japan

Condition
Condition	Stress with operation of the motor vehicle
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this research, by analyzing the cardiovascular response at the time of stress, by applying response measurement of heart rate and pulse wave at the time of audio-visual stimulation by a drive simulator using a head mounted display or a high definition large display, To realize the quantitative evaluation of stress. The ultimate goal is to realize system development to quantify the reaction at the time of driving a car and to prevent traffic accidents.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Perform simulated operation with an automobile driving simulator, and perform electrocardiogram, photoelectric pulse wave, blood pressure measurement. Electrocardiogram electrode, photoelectric pulse wave sensor, blood pressure cuff are used to measure change in electrocardiogram, pulse wave, blood pressure.
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Use a head mounted display or a large display to watch a movie while driving a car and simulate it with an automobile driving simulator, and perform electrocardiogram, photoelectric pulse wave, blood pressure measurement.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Target healthy male and female 20 years of age or older who have a driver's license.
Key exclusion criteria	Motion sickness, people with severe visual sickness are excluded.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Tomoyuki Middle name Last name Yambe
Organization	Tohoku University
Division name	Institute of Development, Aging and Cancer
Zip code	9808575
Address	Seiryo-machi 4-1, Aoba-ku Sendai, 980-8575, JAPAN
TEL	022-717-8517
Email	tomoyuki.yambe.a4@tohoku.ac.jp

Public contact
Name of contact person	1st name akihiro Middle name Last name yamada
Organization	Tohoku University
Division name	Institute of Development, Aging and Cancer
Zip code	9808575
Address	Seiryo-machi 4-1, Aoba-ku Sendai, 980-8575, JAPAN
TEL	022-717-8517
Homepage URL
Email	akihiro.yamada.e1@tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Tohoku University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee Tohoku University Graduate School of Medicine
Address	seiryo 2-1, Aoba-ku, Sendai, 980-8575, JAPAN
Tel	022-717-8007
Email	med-kenkyo@grp.tohoku.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	2017 Year 03 Month 29 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	2014 Year 05 Month 01 Day
Date of IRB	2014 Year 06 Month 03 Day
Anticipated trial start date	2014 Year 07 Month 08 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 03 Month 29 Day
Last modified on	2022 Year 04 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030727