UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032936 |
|---|---|
| Receipt number | R000037546 |
| Scientific Title | 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 | 2020/04/03 01:15:31 |
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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
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
mikita1204@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037546
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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