UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039762 |
|---|---|
| Receipt number | R000045134 |
| Scientific Title | A study on a comprehensive approach to control cognitive decline through five senses stimulation in a healing space-feasibility study |
| Date of disclosure of the study information | 2020/03/10 |
| Last modified on | 2021/11/14 12:18:26 |
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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-feasibility study
Acronym
A study on a comprehensive approach to control cognitive decline through five senses stimulation in a healing space-feasibility study
Scientific Title
A study on a comprehensive approach to control cognitive decline through five senses stimulation in a healing space-feasibility study
Scientific Title:Acronym
A study on a comprehensive approach to control cognitive decline through five senses stimulation in a healing space-feasibility study
Region
| Japan |
Condition
Condition
Dementia dysfunction
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the validity of comprehensive intervention that using "healing space" to provide five senses stimulation for mild cognitive impairment and general elderly to improve QOL and normalize cognitive impairment or reduce symptoms.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in STAI score before and after intervention
Key secondary outcomes
Changes in MMSE-J before and after intervention, Changes in autonomic nervous system before and after intervention or during, NRS changes in side reactions (nausea, vomiting, dizziness, headache, drowsiness), image satisfaction, fragrance and sound comfort.
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Subjects first browses the CG video using the VR, and then browses the live-action video using the VR in the "healing space" using the scent of lemon and rosemary and the natural sound of healing.
Interventions/Control_2
Subjects first browses the live-action video using the VR, and then browses the CG video using the VR in the "healing space" using the scent of lavender and orange and the natural sound of healing.
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
MMSE (Mini-Mental State Examination) Estimated score 21 or higher (out of 30)
Key exclusion criteria
MMSE (Mini-Mental State Examination) Estimated score less than 21 (out of 30)
Target sample size
10
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 | 03 | 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 | 15 | 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 | 03 | 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=R000045134
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
