UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034483 |
|---|---|
| Receipt number | R000039046 |
| Scientific Title | Verification of the effect of mindfulness meditation training tool for Mild Cognitive Impairment prevention |
| Date of disclosure of the study information | 2018/10/15 |
| Last modified on | 2022/08/10 12:05:41 |
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Basic information
Public title
Verification of the effect of mindfulness meditation training tool for Mild Cognitive Impairment prevention
Acronym
Verification of the effect of mindfulness meditation training tool for MCI prevention
Scientific Title
Verification of the effect of mindfulness meditation training tool for Mild Cognitive Impairment prevention
Scientific Title:Acronym
Verification of the effect of mindfulness meditation training tool for MCI prevention
Region
| Japan |
Condition
Condition
Mild Cognitive Impairment
Classification by specialty
| Neurology | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Intervention using a tool to induce a mindfulness state by a meditation method to regulate breathing, we verify effect of emotion conversion and brain function improvement. We focus particularly on whether real time feedback of autonomic nervous conditions results in a significant improvement of autonomic function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
As autonomic nerve evaluation, electrocardiogram CVRR value (Coefficient of Variation of R-R intervals).
We examine the effect difference depending on the presence / absence of the feedback function of the tool, as follows;
(1) Comparison between self-style meditation and meditation induction by tools.
(2) Comparison between self-style meditation before and after the tool intervention period (MCI patient group: 2 weeks, 5 minutes each day in the morning and evening, young healthy group: 4 weeks, 5 minutes once daily).
Key secondary outcomes
TMT (trail making test) as a brain's attention / performance function evaluation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Intervention period: 2 weeks
Intervention amount: 5 minutes each
Frequency: twice daily
Function to feed back the state of the autonomic nerve of the tool that induces the mindfulness state to be used in real time: Yes
Interventions/Control_2
Intervention period: 2 weeks
Intervention amount: 5 minutes each
Frequency: twice daily
Function to feed back the state of the autonomic nerve of the tool that induces the mindfulness state to be used in real time: None
Interventions/Control_3
Intervention period: 4 weeks
Intervention amount: 5 minutes each
Frequency: once a day
Function to feed back the state of the autonomic nerve of the tool that induces the mindfulness state to be used in real time: Yes
Interventions/Control_4
Intervention period: 4 weeks
Intervention amount: 5 minutes each
Frequency: once a day
Function to feed back the state of the autonomic nerve of the tool that induces the mindfulness state to be used in real time: None
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) MCI Patient Group: MCI patient (under 85 years old) visits every week to the day care of our clinic.
(2) Young healthy subject group: Young healthy individuals (30 to 65 years old) who routinely care for dementia patients visiting our clinic.
Key exclusion criteria
(1) Subjects having arrhythmia
(2) Subjects judged as unsuitable for this study by the investigator for other reasons
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Asada |
Organization
Memory Clinic Ochanomizu
Division name
Medical care Division
Zip code
113-0034
Address
4F Ochanomizu Igakukaikan, 1-5-34, Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL
03-6801-8718
asada@memory-cl.jp
Public contact
Name of contact person
| 1st name | Mieko |
| Middle name | |
| Last name | Tanaka |
Organization
Brain Functions Lab., Inc.
Division name
Research Division
Zip code
230-0046
Address
1-508 Leading Venture Plaza, 75-1, Ono-cho, Tsurumi-ku, Yokohama JAPAN
TEL
050-3774-6162
Homepage URL
mtanaka@bfl.co.jp
Sponsor or person
Institute
Memory Clinic Ochanomizu
Institute
Department
Personal name
Funding Source
Organization
Citizen Watch Co., Ltd.
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
Brain Functions Lab., Inc., Research Ethics Committee
Address
LVP1-508, 75-1, Ono-cho, Tsurumi-ku, Yokohama 230-0046 JAPAN
Tel
050-3774-6162
ethics@bfl.co.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
メモリークリニックお茶の水
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 15 | 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
42
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
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 14 | Day |
Last modified on
| 2022 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039046
