UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055708 |
|---|---|
| Receipt number | R000063663 |
| Scientific Title | Epidemiological study to evaluate the effects of short-term exposure to ultrafine particle on olfactory and cognitive functions |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2025/04/03 09:52:42 |
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Basic information
Public title
Epidemiological study to evaluate the effects of short-term exposure to ultrafine particle on olfactory and cognitive functions
Acronym
Short-term exposure to ultrafine particle and olfactory and cognitive functions
Scientific Title
Epidemiological study to evaluate the effects of short-term exposure to ultrafine particle on olfactory and cognitive functions
Scientific Title:Acronym
Short-term exposure to ultrafine particle and olfactory and cognitive functions
Region
| Japan |
Condition
Condition
Not specific
Classification by specialty
| Cardiology | Neurology | Oto-rhino-laryngology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the association between short-term exposure to ultrafine particle on olfactory and cognitive functions
Basic objectives2
Others
Basic objectives -Others
To examine the association between short-term exposure to ultrafine particle on olfactory and cognitive functions
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
olfactory function, cognitive function, and cardiac physiological assessment
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
Breathing air that measured UFP concentrations
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
| 49 | years-old | >= |
Gender
Male
Key inclusion criteria
Never-smokers including heated and/or electric cigarettes.
Men without history of cardiovascular, respiratory, olfactory, and cardiovascular disease
Key exclusion criteria
People who cannot participate in 4 inspections in different seasons during the year.
People who cannot take a half day on weekdays
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takehiro |
| Middle name | |
| Last name | Michikawa |
Organization
Toho University
Division name
Department of Environmental and Occupational Health, School of Medicine
Zip code
143-8540
Address
5-21-16 Omori-nishi, Ota-ku, Tokyo
TEL
+81-3-3762-4151
takehiro.michikawa@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Takehiro |
| Middle name | |
| Last name | Michikawa |
Organization
Toho University
Division name
Department of Environmental and Occupational Health, School of Medicine
Zip code
143-8540
Address
5-21-16 Omori-nishi, Ota-ku, Tokyo
TEL
+81-3-3762-4151
Homepage URL
takehiro.michikawa@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Institute for Environmental Studies, Graduate School of Medicine, Hokkaido University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the Faculty of Medicine, Toho University
Address
5-21-16 Omori-nishi, Ota-ku, Tokyo
Tel
+81-3-3762-4151
med.rinri@ext.toho-u.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
| 2024 | Year | 12 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 10 | Month | 02 | Day |
Last modified on
| 2025 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063663
