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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034483
Receipt No. 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 2019/07/22

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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
Email 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
Email mtanaka@bfl.co.jp

Sponsor
Institute Memory Clinic Ochanomizu
Institute
Department

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
Email 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
2019 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039046

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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