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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038437
Receipt No. R000043799
Scientific Title Neuroscientific investigation of the effect of odor on the attentional state during simulated driving
Date of disclosure of the study information 2019/11/01
Last modified on 2019/10/30

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Basic information
Public title Neuroscientific investigation of the effect of odor on the attentional state during simulated driving
Acronym Neuroscientific investigation of the effect of odor on the attentional state during simulated driving
Scientific Title Neuroscientific investigation of the effect of odor on the attentional state during simulated driving
Scientific Title:Acronym Neuroscientific investigation of the effect of odor on the attentional state during simulated driving
Region
Japan

Condition
Condition healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of odor on the attentional state during simulated driving from the brain activity
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Attention related brain activity
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 odor simulation
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

Not applicable
Gender Male and Female
Key inclusion criteria - healthy student
- over 18 years old
- male and female
- car license
Key exclusion criteria - neurology and psychiatry disorder
- left handedness
- having metal inside and surface of the body
- claustrophobia, darkness fobia
- tattoo
- pregnancy
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Motoaki
Middle name
Last name Sugiura
Organization Tohoku University
Division name Institute of Development, Aging and Cancer
Zip code 9808575
Address 4-1 Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-8563
Email motoaki.sugiura.d6@tohoku.ac.jp

Public contact
Name of contact person
1st name Kentaro
Middle name
Last name Oba
Organization Tohoku University
Division name Institute of Development, Aging and Cancer
Zip code 9808575
Address 4-1 Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-8563
Homepage URL
Email kentaro.oba.c6@tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization DENSO CORPORATION
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Research Ethics Committee of Tohoku University School of Medicine
Address 2-1 Seiryo-machi, Aoba-ku, Sendai
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
2019 Year 11 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 09 Month 13 Day
Date of IRB
Anticipated trial start date
2019 Year 11 Month 20 Day
Last follow-up date
2020 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 10 Month 30 Day
Last modified on
2019 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043799

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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