UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038437 |
|---|---|
| Receipt number | 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 13:44:21 |
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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
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
kentaro.oba.c6@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043799
