UMIN-CTR Clinical Trial

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