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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040380
Receipt No. 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

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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
Email 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
Email okutanif@kochi-u.ac.jp

Sponsor
Institute Kochi Medical School
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046051

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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