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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033776
Receipt No. R000038527
Scientific Title The effect of continuous use of odor in elderly subjects
Date of disclosure of the study information 2018/08/20
Last modified on 2018/08/16

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Basic information
Public title The effect of continuous use of odor in elderly subjects
Acronym Odor stimuli and cognitive function
Scientific Title The effect of continuous use of odor in elderly subjects
Scientific Title:Acronym Odor stimuli and cognitive function
Region
Japan

Condition
Condition Healthy elderly subjects
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of continuous odor stimuli on
improving cognitive function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Evaluation of cognitive functions after one-month
continuous odor stimuli.
Key secondary outcomes Evaluation of subjective feeling of their health and activityafter one-month continuous odor stimuli.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Pseudo-randomization

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Assigning to smell target odor once a day for one month, and writing diaries every day.
Interventions/Control_2 Assigning to smell placebo odor once a day for one month, and writing diaries every day.
Interventions/Control_3 Assigning to not smell odor and writing diaries every day.
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
55 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Healthy elderly subjects
Key exclusion criteria -Subjects with psychiatric illness, past cerebral infarction, and subjects diagnosed as sinusitis or nasal allergy havinganosmia in the past.

-Subjects now having sinusitis, symptom of nasal allergy with nasal discharge or nasal congestion.

-Subjects now receiving regular outpatient treatment and having nasal allergy and anosmia.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuri Masaoka
Organization Showa University School of Medicine
Division name Department of Physiology
Zip code
Address 1-5-8 Hatanodai, Shinagawaku. Tokyo, Japan
TEL +81-3-3784-8113
Email faustus@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuri Masaoka
Organization Showa University School of Medicine
Division name Department of Physiology
Zip code
Address 1-5-8 Hatanodai, Shinagawaku. Tokyo, Japan
TEL +81-3-3784-8113
Homepage URL
Email faustus@med.showa-u.ac.jp

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
Organization
Division
Category of Funding Organization Profit organization
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 東京都目黒区シルバー人材センター

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 20 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 Preinitiation
Date of protocol fixation
2018 Year 06 Month 08 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 10 Day
Last follow-up date
2018 Year 11 Month 10 Day
Date of closure to data entry
2018 Year 11 Month 20 Day
Date trial data considered complete
2018 Year 12 Month 10 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 08 Month 16 Day
Last modified on
2018 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038527

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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