UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022108
Receipt number 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 18:17:36

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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 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


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

Value
https://center6.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