UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062587 |
|---|---|
| Receipt number | R000071469 |
| Scientific Title | Study on brain function in response to olfactory stimuli |
| Date of disclosure of the study information | 2026/08/16 |
| Last modified on | 2026/08/16 13:18:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Research investigating how the brain works when we smell
Acronym
Research on Odor and Brain Function
Scientific Title
Study on brain function in response to olfactory stimuli
Scientific Title:Acronym
olfactory test
Region
| Japan |
Condition
Condition
olfactory disfunction
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the brain activity involved when humans consciously perceive odors
Basic objectives2
Others
Basic objectives -Others
olfactory physiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in activity and inhibition areas in magnetoencephalography (MEG) data before and after olfactory stimulation
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
| Medicine |
Interventions/Control_1
The reagents used in olfactory testing are classified as pharmaceuticals. These include beta-Phenylethyl alcohol, Methyl cyclopentenolone, Isovaleric acid, ganma-undecalactone, and Skatole.
Two of the following reagents are used during the preliminary olfactory test and MEG measurement: beta-Phenylethyl alcohol, Methyl cyclopentenolone, and ganma-undecalactone.
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals who meet all of the following selection criteria and do not meet any of the exclusion criteria will be included as research participants in this study.
1. Individuals who have the willingness and ability to provide informed consent of their own free will.
2. Individuals who have given written consent to participate in the study.
3. Individuals aged 18 to 40 years at the time of obtaining consent.
4. Individuals with normal olfactory function (average recognition threshold of 1.0 or less) as measured by the standard olfactory function test.
Key exclusion criteria
Individuals who are pregnant or planning to become pregnant at the time of obtaining consent.
Individuals with abnormal findings in the nasal cavity.
Individuals unsuitable for MRI scans or magnetoencephalography measurements.
Individuals with metal implants in their bodies, cardiac pacemakers, artificial heart valves, cochlear implants/middle ears, non-titanium brain aneurysm clips, artificial joints, bolt fixation for fractures, magnetic dentures or other magnetic materials implanted in the body, implants, orthodontic appliances, tattoos, permanent makeup, IUDs, or metal in the eyes
Individuals with claustrophobia.
Individuals with a history of hyperventilation.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kishiko |
| Middle name | |
| Last name | Sunami |
Organization
Osaka Metropolitan University
Division name
otolaryngology
Zip code
5458585
Address
Asahimachi osaka Abenoku
TEL
0666453871
gr-med-jibika@omu.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Amesara |
Organization
Osaka Metropolitan University
Division name
otolaryngology
Zip code
5458585
Address
Asahimachi Osaka Abenoku
TEL
06-6645-3871
Homepage URL
am_mi_mi@yahoo.co.jp
Sponsor or person
Institute
Osaka metropolitan university
Institute
Department
Personal name
Funding Source
Organization
none
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
osaka metropolitan university
Address
Asahimachi, Osaka Abeno-ku
Tel
0666453871
gr-med-jibika@omu.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
| 2026 | Year | 08 | Month | 16 | 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
| 2026 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2030 | Year | 08 | 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
| 2026 | Year | 08 | Month | 16 | Day |
Last modified on
| 2026 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071469
