UMIN-CTR Clinical Trial

Basic information
Public title	The evaluation of the efficacy of olfactory stimulation as a means of improving cognitive function: A randomised controlled trial
Acronym	The evaluation of the efficacy of olfactory stimulation as a means of improving cognitive function: A randomised controlled trial
Scientific Title	The evaluation of the efficacy of olfactory stimulation as a means of improving cognitive function: A randomised controlled trial
Scientific Title:Acronym	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	1st name Hajime Middle name Last name Tabuchi
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL	03-3353-1211
Email	tabuchi@a8.keio.jp

Public contact
Name of contact person	1st name Mika Middle name Last name Konishi
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Zip code	160-8582
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)

IRB Contact (For public release)
Organization	Keio University Hospital Clinical and Translational Research Center
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
Tel	03-3353-1211
Email	keio@esct.bvits.com keio.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	2018 Year 06 Month 11 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	120
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	No longer recruiting
Date of protocol fixation	2018 Year 12 Month 25 Day
Date of IRB	2018 Year 12 Month 25 Day
Anticipated trial start date	2019 Year 01 Month 10 Day
Last follow-up date	2019 Year 06 Month 07 Day
Date of closure to data entry	2019 Year 07 Month 03 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 06 Month 10 Day
Last modified on	2020 Year 04 Month 03 Day

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