UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046310 |
|---|---|
| Receipt number | R000052831 |
| Scientific Title | A novel strategy for prevention of cognitive decline and stress care using a "smart healing space" that stimulates the five senses - An integrative medical approach based on co-creation between humans and the latest technology |
| Date of disclosure of the study information | 2021/12/07 |
| Last modified on | 2021/12/07 21:55:57 |
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Basic information
Public title
Development of a novel method to prevent cognitive decline using a "healing smart space" that stimulates the five senses
Acronym
Development of a novel dementia prevention method using a "healing smart space" that stimulates the five senses
Scientific Title
A novel strategy for prevention of cognitive decline and stress care using a "smart healing space" that stimulates the five senses - An integrative medical approach based on co-creation between humans and the latest technology
Scientific Title:Acronym
A novel strategy for prevention of cognitive decline and stress care using a "healing smart space" that stimulates the five senses
Region
| Japan |
Condition
Condition
Mild cognitive impairment, behavior and psychological symptoms of dementia, stress
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To propose a new method to efficiently control cognitive decline and provide stress care through the development of a "healing smart space" that simultaneously stimulates multiple human senses.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the Japanese version of the Montreal Cognitive Assessment (MoCA-J) between baseline and post-intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention group will perform reminiscence using the Healing Smart Space once a week for 3 months, and subjective and objective assessments will be conducted. Subjective assessments will include MMSE-J, MoCA-J, Motivation Score, J-ZBI, DBD13, CDR-J, PSMS, IADL, the Gerontological Activity Capacity Index, STAI, and NRS for satisfaction, emotion, and adverse reactions. Objective assessments will include autonomic balance analysis, EEG analysis, voice analysis, eye tracking analysis, and blood biomarker analysis. The objective evaluation will include autonomic balance analysis, EEG analysis, voice analysis, eye tracking analysis, and blood biomarker analysis.
Interventions/Control_2
In the control group (monitor viewing group), the same subjective and objective evaluations as in the intervention group will be conducted.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1.20 years of age or older
2.A client of the Misasagikai Elderly Care Center
3.MMSE-J score of 16 or higher
4.Have not started using donepezil, rivastigmine, galantamine, or memantine within the last 3 months.
5.Consent will be obtained from the individual to participate in this study.
Key exclusion criteria
1.Under 20 years old.
2.MMSE-J score of 15 or less.
3.Have a visual impairment that prevents recognition of images even when vision is corrected with glasses, etc.
4.Have hearing impairment to the extent that they cannot hear sounds even with the use of hearing aids.
5.Self-reported susceptibility to motion sickness or VIMS.
6.Has difficulty in sitting up.
7.Cognitive function has declined to the extent that the patient is unable to answer the questionnaire (e.g., communication is not possible even with support when answering).
8.Has started donepezil, rivastigmine, galantamine, or memantine within the last 3 months.
9.Is judged by the principal investigator to be inappropriate for participation in this study.
Target sample size
60
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
head of an office
Zip code
536-8588
Address
Osaka, Joto-ku, Morinomiya 1-6-107
TEL
06-6969-6711
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
head of an office
Zip code
536-8588
Address
Osaka, Joto-ku, Morinomiya 1-6-107
TEL
06-6969-6711
Homepage URL
juki@osaka-ganjun.jp
Sponsor or person
Institute
Osaka Center for Cancer and Cardiovascular Disease Prevention
Institute
Department
Personal name
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 Ethical Review Boards
Address
Osaka, Joto-ku, Morinomiya 1-6-107
Tel
06-6969-6711
juki@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
| 2021 | Year | 12 | Month | 07 | 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
| 2021 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2025 | 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
| 2021 | Year | 12 | Month | 07 | Day |
Last modified on
| 2021 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052831
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