UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057431 |
|---|---|
| Receipt number | R000065620 |
| Scientific Title | A Comparative Study of Olfaction and Cognitive Impact in Elderly Patients with and without Passive Olfaction Training Intervention |
| Date of disclosure of the study information | 2025/03/27 |
| Last modified on | 2025/03/27 22:26:20 |
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Basic information
Public title
A Comparative Study of Olfaction and Cognitive Impact in Elderly Patients with and without Passive Olfaction Training Intervention
Acronym
olfactory function and cognition
Scientific Title
A Comparative Study of Olfaction and Cognitive Impact in Elderly Patients with and without Passive Olfaction Training Intervention
Scientific Title:Acronym
olfactory function and cognition
Region
| Japan |
Condition
Condition
olfactory and cognitive function
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A 12-week study will be conducted to determine if olfactory training (a method in which fragrances are dangled like pendants and sniffed simultaneously with normal breathing in daily life) can prevent cognitive decline in people 65 years of age and older than if it is not performed. The study will consist of questions, sniffing tests, and cognitive function tests.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cognitive function
Key secondary outcomes
olfactory function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Aroma
Interventions/Control_2
No aroma
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A minimum score of 24 on the cognitive function test MMSE, which is performed after consent is obtained.
Key exclusion criteria
1 When there is nasal obstruction
2 When the patient has been diagnosed with dementia
3 When a cognitive function test cannot be performed
4 Patients who have requested the use of fragrances before enrollment in the study, or who have expressed refusal to use fragrances
5 The patient has a mental disorder or other illness that affects cognitive function or is undergoing treatment or prevention that affects cognitive function
6 Other cases in which the principal investigator/associate investigator deems the patient to be excluded due to safety issues or other reasons
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | SHO |
| Middle name | |
| Last name | KANZAKI |
Organization
National Institute of Sensory Organ, National Hospital Organization of Tokyo Medical Center
Division name
Laboratory of Auditory Disorders,Auditory and Balance Research Division
Zip code
152-8902
Address
2-5-1 Higashigaoka Meguro Tokyo, Japan
TEL
0334110111
shokanza@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Kanzaki |
Organization
National Institute of Sensory Organ, National Hospital Organization of Tokyo Medical Center
Division name
Laboratory of Auditory Disorders, Auditory and Balance Research Division
Zip code
152-8902
Address
2-5-1 Higashigaoka Meguro Tokyo
TEL
0353633827
Homepage URL
shokanza@yahoo.co.jp
Sponsor or person
Institute
National Institute of Sensory Organ, National Hospital Organization of Tokyo Medical Center
Institute
Department
Personal name
Funding Source
Organization
Kose cosmetology research foundation
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
Ethics Committee of National Hospital Organization Tokyo Medical Center
Address
2-5-1 Higashigaoka Meguro Tokyo
Tel
0334110111
shokanza@yahoo.co.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
| 2025 | Year | 03 | Month | 27 | 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
| 2024 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 03 | Month | 27 | 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
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 27 | Day |
Last modified on
| 2025 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065620
