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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000022108
Receipt No. R000025209
Scientific Title Is olfactory stimulation effective on olfactory recovery?
Date of disclosure of the study information 2016/04/27
Last modified on 2016/11/02

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Basic information
Public title Is olfactory stimulation effective on olfactory recovery?
Acronym Is olfactory stimulation effective on olfactory recovery?
Scientific Title Is olfactory stimulation effective on olfactory recovery?
Scientific Title:Acronym Is olfactory stimulation effective on olfactory recovery?
Region
Japan

Condition
Condition Olfactory dysfunction
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify whether olfactory stimulation is effective on olfactory recovery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Results of T&T olfactometry and Open Essence tests.(Every three months)
Key secondary outcomes Symptoms of patients.(Every three months)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Chemicals used for olfactory training should keep vaporizing odor for 3 months without degradation or decay. As familiar odors to Japanese people, we selected Vanilla, Yuzu, Peach, Caramel, Rose, and Lemon for olfactory training.
We put 10 ml of these odorous chemicals each in brown glass vial bottles. A piece of cotton wool is inserted for absorbing chemicals. The training kit include 4 bottles in a plastic case.
Patients are asked to sniff these odors for 15 seconds by twice. Every day they are instructed to do training twice or three times a day.
Chemicals used for olfactory training were changed at October, 2016. Now we use flavors of Coffee, Blueberry, Pineapple, and Peppermint.
Interventions/Control_2
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
18 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria Patients with olfactory dysfunction due to after infection or head trauma.
Key exclusion criteria Patients without enough recognition ability to do olfactory training.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumino Okutani
Organization Kochi Medical School
Division name Department of Occupational Health,
Zip code
Address Nankoku, Kochi 783-8505
TEL 088-880-2560
Email okutanif@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fumino Okutani
Organization Kochi Medical School
Division name Department of Occupational Health,
Zip code
Address Nankoku, Kochi 783-8505
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
Address
Tel
Email

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 高知大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2016 Year 04 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
Date of protocol fixation
2016 Year 01 Month 06 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 27 Day
Last modified on
2016 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025209

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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