UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033776 |
|---|---|
| Receipt number | R000038527 |
| Scientific Title | The effect of continuous use of odor in elderly subjects |
| Date of disclosure of the study information | 2018/08/20 |
| Last modified on | 2022/08/25 13:55:00 |
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Basic information
Public title
The effect of continuous use of odor in elderly subjects
Acronym
Odor stimuli and cognitive function
Scientific Title
The effect of continuous use of odor in elderly subjects
Scientific Title:Acronym
Odor stimuli and cognitive function
Region
| Japan |
Condition
Condition
Healthy elderly subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of continuous odor stimuli on
improving cognitive function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Evaluation of cognitive functions after one-month
continuous odor stimuli.
Key secondary outcomes
Evaluation of subjective feeling of their health and activityafter one-month continuous odor stimuli.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Assigning to smell target odor once a day for one month, and writing diaries every day.
Interventions/Control_2
Assigning to smell placebo odor once a day for one month, and writing diaries every day.
Interventions/Control_3
Assigning to not smell odor and writing diaries every day.
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
| 55 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy elderly subjects
Key exclusion criteria
-Subjects with psychiatric illness, past cerebral infarction, and subjects diagnosed as sinusitis or nasal allergy havinganosmia in the past.
-Subjects now having sinusitis, symptom of nasal allergy with nasal discharge or nasal congestion.
-Subjects now receiving regular outpatient treatment and having nasal allergy and anosmia.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuri |
| Middle name | |
| Last name | Masaoka |
Organization
Showa University School of Medicine
Division name
Department of Physiology
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawaku. Tokyo, Japan
TEL
+81-3-3784-8113
faustus@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuri |
| Middle name | |
| Last name | Masaoka |
Organization
Showa University School of Medicine
Division name
Department of Physiology
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawaku. Tokyo, Japan
TEL
+81-3-3784-8113
Homepage URL
faustus@med.showa-u.ac.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao 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
Ethical Committees of Showa University School of Medicine
Address
1-5-8 Hatanodai, Shinagawaku, Tokyo Japan
Tel
+81-3-3784-8129
ctsc.admin@ofc.showa-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
東京都目黒区シルバー人材センター
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8369471/
Publication of results
Unpublished
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8369471/
Number of participants that the trial has enrolled
30
Results
We used functional magnetic resonance imaging to investigate the relationship between blood oxygen levels in olfactory regions and odor-induced subjective memory retrieval in older adults. We found that strength of memory retrieval and of the emotions induced by odor-evoked autobiographical memories directly influenced neural changes in the left fusiform gyrus, and impacted left posterior orbitofrontal cortex activation through the leftfusiform response.
Results date posted
| 2022 | Year | 08 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
All participants had normal cognitive function. No participants had a personal history of seizures or head injury, or a diagnosis of a neurological or psychiatric disorder.
Participant flow
1. Measured cognitive assessment and olfactory acuity
test
2. Brain activity measured with functional magnetic resonance
3. Measured subjective scale
Adverse events
None
Outcome measures
Brain activity level measured with functional magnetic resonance
Results of cognitive assessment and olfactory acuity test
Results of subjective scales
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 10 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 20 | Day |
Date trial data considered complete
| 2021 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 16 | Day |
Last modified on
| 2022 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038527
