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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032936
Receipt No. R000037546
Official scientific title of the study The evaluation of the efficacy of olfactory stimulation as a means of improving cognitive function: A randomised controlled trial
Date of disclosure of the study information 2018/06/11
Last modified on 2018/06/16

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Basic information
Official scientific title of the study The evaluation of the efficacy of olfactory stimulation as a means of improving cognitive function: A randomised controlled trial
Title of the study (Brief title) The evaluation of the efficacy of olfactory stimulation as a means of improving cognitive function: A randomised controlled trial
Region
Japan

Condition
Condition healthy elderly people
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether the rehabilitation of odor stimulation to health elderly people have an efficacy for the improvement of cognitive function, mental condition and olfactory function
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes PASAT(Paced Auditory Serial Addition Test)
Key secondary outcomes MMSE, PHQ-9, GAD-7, SDISS,Well-being(the relevant four items from CES-D), RAVLT, Symbol Digit Modalities Test, Pittsburgh Sleep Quality Index, T&T Olfactometer

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Odor stimulation by aromas (two hours exposure to odor stimulation twice a day in the morning and evening over three months)
Interventions/Control_2 Odor stimulation by ethanol (two hours exposure to odor stimulation twice a day in the morning and evening over three months)
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
65 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Ability to both understand and agree with informed consent in Japanese

Ability to perform the all tests required on the designated day after the agreement with informed consent

A score of 24 or more on the MMSE

Olfactory ability demonstrated as normal by the test of T&T olfactometer
Key exclusion criteria Any substance addiction (except nicotine addiction) in the current or past history

Education history of 6 years or less

Any substance addiction (except nicotine addiction) in the current or past history

Currently receiving any psychotropic medication such as antidepressant, antipsychotics or tranquilizers including sleeping pills

Medical history of psychiatric or neurological diseases, including schizophrenia, depressive disorders or anxiety disorders, potentially influencing the olfactory ability (ruled out by the M.I.N.I.(Mini-International Neuropsychiatric Interview)

Severe physical disease including liver, renal or endocrine disability

Any disease potentially causing the olfactory disability

Routinely receiving aromatherapy treatments

Routinely using softener, fragrance or perfume with strong smell
Target sample size 120

Research contact person
Name of lead principal investigator Hajime Tabuchi
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL 03-3353-1211
Email tabuchi@a8.keio.jp

Public contact
Name of contact person Mika Konishi
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL 03-3353-1211
Homepage URL
Email mikita1204@keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization The Research Institute of Economy, Trade and Industry(RIETI)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 06 Month 11 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 06 Month 08 Day
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 06 Month 10 Day
Last modified on
2018 Year 06 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037546

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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