UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048601 |
|---|---|
| Receipt number | R000055378 |
| Scientific Title | Research on odor perception |
| Date of disclosure of the study information | 2022/08/05 |
| Last modified on | 2022/08/05 14:37:15 |
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Basic information
Public title
Research on odor perception
Acronym
Research on odor perception
Scientific Title
Research on odor perception
Scientific Title:Acronym
Research on odor perception
Region
| Japan |
Condition
Condition
postpartum psychosis
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will expand on previous research, measure brain activity using fMRI, quantify hormones involved in emotions such as oxytocin and corticoids, and investigate the physiological effects that occur with emotional changes caused by odors in newborns. be. Through this research, we will elucidate part of the action mechanism of odor communication by newborns, and further advance this research to scientifically deepen our understanding of human emotions, and attach to newborns as a social outlet for research results. The purpose is to contribute to solving social problems such as the prevention of abuse, such as the development of fragrances that encourage
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We will image changes in brain activity caused by olfactory, visual, and auditory stimuli using fMRI, and compare and analyze the physiological effects that occur with emotional changes caused by odors (especially in newborns) by comparing them with other stimuli. Analysis software such as SPM is used to compare imaging data during stimulus presentation obtained by block design and imaging data at rest.
Key secondary outcomes
In parallel with fMRI imaging, oxytocin and corticoid hormones, which are involved in human emotions, were quantified by collecting saliva. Analysis is performed by t-test. In addition, a psychological questionnaire about odors will be conducted. Statistical analysis examined whether there was a significant difference between the presence and absence of odor stimuli in changes in hormone levels quantified by luminance measurement, and fitted a generalized linear model to the correlation with scores from psychological questionnaires. , to perform a likelihood ratio test.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
none
Key exclusion criteria
none
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazunao |
| Middle name | |
| Last name | Suzuki |
Organization
Hamamastu University School of Medicine
Division name
Obstetrics&Gynecology
Zip code
431-3192
Address
Handayama1-20-1
TEL
0534352309
dallascowboys1018@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kazunao |
| Middle name | |
| Last name | Suzuki |
Organization
Hamamastu University School of Medicine
Division name
Obstetrics&Gynecology
Zip code
431-3192
Address
Handayama1-20-1
TEL
0534352309
Homepage URL
kazunaos@hama-med.ac.jp
Sponsor or person
Institute
Hamamastu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
mnone
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
Hamamastu University School of Medicine
Address
Handayama1-20-1
Tel
0534352309
kazunaos@hama-med.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
浜松医科大学
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 05 | 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
Suspended
Date of protocol fixation
| 2021 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 08 | Month | 05 | Day |
Last modified on
| 2022 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055378
