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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040350
Receipt No. R000045202
Scientific Title A study on a comprehensive approach to control cognitive decline through five senses stimulation in a healing space
Date of disclosure of the study information 2020/05/10
Last modified on 2020/05/10

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Basic information
Public title A study on a comprehensive approach to control cognitive decline through five senses stimulation in a healing space
Acronym A study on a comprehensive approach to control cognitive decline through five senses stimulation in a healing space
Scientific Title A study on a comprehensive approach to control cognitive decline through five senses stimulation in a healing space
Scientific Title:Acronym A study on a comprehensive approach to control cognitive decline through five senses stimulation in a healing space
Region
Japan

Condition
Condition Cognitive impairment
Classification by specialty
Neurology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To improve quality of life and normalize or
reduce symptoms of cognitive impairment by providing comprehensive, drug-free interventions for people with mild cognitive impairment (MCI) and other pre-dementia patients by reviewing their lifestyle habits and providing "healing environments" that provide sensory stimulation.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of MMSE estimated and measured scores before and after intervention
Key secondary outcomes Changes in STAI score, NRS, motivation score, DBD-13, J-ZBI by caregivers (family, caregiver), autonomic nervous function test (tas9), EEG measurement of subjects before and after intervention

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Once a week,a sensory stimulation approach is used. Vision is stimulated by virtual reality,hearing is stimulated by high-resolution sound sources according to the images,smell is stimulated by aromatic essential oils,taste is stimulated by citrus foods,and touch is stimulated by occupational therapy.
Interventions/Control_2 Regular care provided in nursing homes
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

Not applicable
Gender Male and Female
Key inclusion criteria 24 or more MMSE (Mini-Mental State Examination) Estimated score 27 or less (out of 30)
Key exclusion criteria MMSE (Mini-Mental State Examination) Estimated score less than 24 (out of 30)
Target sample size 40

Research contact person
Name of lead principal investigator
1st name TOSHINORI
Middle name
Last name ITO
Organization Osaka Center for Cancer and Cardiovascular Disease Prevention
Division name Osaka Center for Cancer and Cardiovascular Disease Prevention
Zip code 536-8588
Address 1-6-107,MORINOMIYA, OSAKA JOTO-KU, OSAKA
TEL 06-6969-6711
Email juki@osaka-ganjun.jp

Public contact
Name of contact person
1st name TOSHINORI
Middle name
Last name ITO
Organization Osaka Center for Cancer and Cardiovascular Disease Prevention
Division name Osaka Center for Cancer and Cardiovascular Disease Prevention
Zip code 536-8588
Address 1-6-107,MORINOMIYA, OSAKA JOTO-KU, OSAKA
TEL 06-6969-6711
Homepage URL
Email juki@osaka-ganjun.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization Osaka University
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 Osaka Center for Cancer and Cardiovascular Disease Prevention
Address 1-6-107,MORINOMIYA, OSAKA JOTO-KU, OSAKA
Tel 06-6969-6711
Email kiyama@osaka-ganjun.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
2020 Year 05 Month 10 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 Enrolling by invitation
Date of protocol fixation
2019 Year 10 Month 28 Day
Date of IRB
2019 Year 10 Month 28 Day
Anticipated trial start date
2019 Year 10 Month 28 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 05 Month 10 Day
Last modified on
2020 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045202

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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