UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040376 |
|---|---|
| Receipt number | R000044791 |
| Scientific Title | Effectiveness of Japanese version of olfactory training |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2025/10/07 16:27:46 |
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Basic information
Public title
Effectiveness of Japanese version of olfactory training
Acronym
Japanese olfactory training
Scientific Title
Effectiveness of Japanese version of olfactory training
Scientific Title:Acronym
Effectiveness of Japanese version of olfactory training
Region
| Japan |
Condition
Condition
olfactory dysfunction patient
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effectiveness of olfactory training in Japanese population and whether odor would be the factor of its effetiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare the scores of questionnaire which assess the patient's symptom and olfactory test score between before and after 12 weeks olfactory training.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
12 weeks olfactory training (Original method which is reported abroad)
Interventions/Control_2
12 weeks olfactory training (with the familiar odors for Japanese)
Interventions/Control_3
12 weeks olfactory training (with the non-familiar odors for Japanese)
Interventions/Control_4
Only ordinary medication group
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Post infectious olfactory dysfunction
Post - traumatic olfactory dysfunction
Key exclusion criteria
Sinusitis
Neurodegenerative disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ayaho |
| Middle name | |
| Last name | Yoshino |
Organization
Nippon medical school
Division name
Oto rhino laryngology
Zip code
113-8603
Address
Sendagi 1-1-5, Bunkyo-ku, Tokyo
TEL
03-3822-2131
yoshinoayaho@nms.ac.jp
Public contact
Name of contact person
| 1st name | Ayaho |
| Middle name | |
| Last name | Yoshino |
Organization
Nippon medical school
Division name
Oto rhino laryngology
Zip code
113-8603
Address
Sendagi 1-1-5, Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
yoshinoayaho@nms.ac.jp
Sponsor or person
Institute
Nippon medical school
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
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
Nippon medical school
Address
Sendagi 1-1-5, Bunkyo-ku, Tokyo
Tel
03-3822-2131
yoshinoayaho@nms.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
日本医科大学付属病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://karger.com/orl/article/doi/10.1159/000547489/930849/Familiarity-with-Odors-Does-Not-Play-a-R
Publication of results
Published
Result
URL related to results and publications
https://karger.com/orl/article/doi/10.1159/000547489/930849/Familiarity-with-Odors-Does-Not-Play-a-R
Number of participants that the trial has enrolled
60
Results
Significant improvements were observed in olfactory detection threshold and recognition threshold function and retronasal olfactory function tests across all groups following OT. However, there was no significant effect observed on OE score. Furthermore, no significant differences were found among the OG, FG, and UFG groups.
Results date posted
| 2025 | Year | 10 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Data were collected from May 2020 to December 2023.
Participant flow
All participants were recruited at the Otorhinolaryngology Department Outpatient Clinic at Nippon Medical School Hospital.
Adverse events
non
Outcome measures
Olfactory function was evaluated using T&T olfactometry (combined odor detection threshold and odor recognition threshold test), intravenous olfactory test (retronasal olfactory test), and an open essence (OE) (odor identification test)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 30 | 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
| 2025 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044791
