UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040350 |
|---|---|
| Receipt number | 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 | 2021/11/14 12:18:56 |
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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
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
juki@osaka-ganjun.jp
Sponsor or person
Institute
Osaka University
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
Address
1-6-107,MORINOMIYA, OSAKA JOTO-KU, OSAKA
Tel
06-6969-6711
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
| 2021 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.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 |
