UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040380 |
|---|---|
| Receipt number | R000046051 |
| Scientific Title | Establishment of olfactory training for Japanese people by comparison with European methods |
| Date of disclosure of the study information | 2020/06/30 |
| Last modified on | 2020/05/12 18:59:31 |
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Basic information
Public title
Establishment of olfactory training for Japanese people by comparison with European methods
Acronym
Olfactory training for Japanese people
Scientific Title
Establishment of olfactory training for Japanese people by comparison with European methods
Scientific Title:Acronym
Olfactory training for Japanese people
Region
| Japan |
Condition
Condition
Post-viral olfactory dysfunction, Traumatic olfactory dysfunction, Olfactory dysfunction by unknown cause
Classification by specialty
| Neurology | Oto-rhino-laryngology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of olfactory training for Japanese people. For olfactory training for Japanese people, odorants that are familiar for Japanese people should be used. Using olfactory tests for Japanese, olfaction should be assessed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Does olfaction improve by Japanese style olfactory training as well as European style? Olfaction should be assessed by Japanese olfactory tests.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Olfactory training consists of 2 sets of sniffing 4 kinds of odors twice for 15 seconds each. Participants are asked to continue for 9 months.
Interventions/Control_2
One group is exposed to European style olfactory training, and the other group is exposed to Japanese style olfactory training.
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
| 16 | years-old | < |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with olfactory dysfunction by post-viral, head trauma and unknown cause. They should not have any other neurological symptoms. Enough cognitive function to carry out olfactory training should be required.
Key exclusion criteria
Patients with conductive olfactory loss with rhino-sinusitis confirmed by CT scans.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Fumino |
| Middle name | |
| Last name | Okutani |
Organization
Kochi Medical School
Division name
Department of Occupational Health
Zip code
783-8505
Address
Nankoku, Kochi
TEL
088-880-2560
okutanif@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Fumino |
| Middle name | |
| Last name | Okutani |
Organization
Kochi Medical School
Division name
Department of Occupational Health
Zip code
783-8505
Address
Nankoku, Kochi
TEL
088-880-2560
Homepage URL
okutanif@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School
Institute
Department
Personal name
Funding Source
Organization
Kochi Medical School
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
Integrated Center for Advanced Medical Technologies
Address
Nankoku, Kochi
Tel
088-866-5811
is21@kochi-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
| 2020 | Year | 06 | Month | 30 | 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
| 2020 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2025 | 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
| 2020 | Year | 05 | Month | 12 | Day |
Last modified on
| 2020 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046051
