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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037099
Receipt No. R000042271
Scientific Title Auditory Cognitive Training with Low-Volume Sounds Improves Brain Plasticity and Cognitive Functions
Date of disclosure of the study information 2019/06/25
Last modified on 2021/01/13

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Basic information
Public title Auditory Cognitive Training with Low-Volume Sounds Improves Brain Plasticity and Cognitive Functions
Acronym Auditory Cognitive Training with Low-Volume Sounds Improves Brain Plasticity and Cognitive Functions
Scientific Title Auditory Cognitive Training with Low-Volume Sounds Improves Brain Plasticity and Cognitive Functions
Scientific Title:Acronym Auditory Cognitive Training with Low-Volume Sounds Improves Brain Plasticity and Cognitive Functions
Region
Japan

Condition
Condition Normal elderly people
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine beneficial effects on brain plasticity and cognitive functions of an acoustic intervention with low volume auditory stimuli.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Stroop task, Word fluency test, Raven's Colored Progressive Materices, Japanese Reading Ability Test, Logical memory, Digit Span, D-CAT(digit cancellation test), Digit symbol coding, Find-symbol, Mental rotation, MMSE (Mini-Mental State Examination), HHIE (Hearing Handicap Inventory for Elderly, fMRI (functional magnetic resonance imaging), Audiometry test
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Intervention group A, a week using the hearing recognition task for about 1 hour for 4 weeks.
Interventions/Control_2 Intervention group A, a week using the hearing recognition task for about 1 hour for 4 weeks.
Interventions/Control_3 Intervention group A, a week using the hearing recognition task for about 1 hour for 4 weeks.
Interventions/Control_4 Intervention group A, a week using the hearing recognition task for about 1 hour for 4 weeks.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
60 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria The subjects were 80 healthy right-handed elderly men and women (age: 60 to 80) whose native language is Japanese.
Key exclusion criteria Have a history of mental illness, diabetes, cranial nerve disease, heart disease (heart disease)
Taking medications that affect cognitive function (e.g., benzodiazepines, antidepressants, central nervous system drugs)
The score for the MMSE (Mini-Mental State Examination), a screening test for dementia, is 24 or less
Five or more tests (Geriatric Depression Scale) to check the degree of depression
Problems with hearing problems related to hearing (e.g. middle ear, ear problems, tinnitus, etc)
Hearing test average 25 dB or more
HHIE (Hearing Handicap Inventory Elderly) is 44% or less
If you are currently participating in another study, you have participated in another study within two months before the start of the study
If there is metal in the body or claustrophobia, it is not a subject because it is dangerous for MRI examination
Those who cannot participate in pre- and post-tests conducted before and after the intervention period
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Kawashima
Middle name
Last name Ryuta
Organization Tohoku University
Division name Tohoku University Institute of Development, Aging and Cancer applied brain science research
Zip code 980-8575
Address Sendai City Aoba-ku Seiryocho 4-1
TEL 022-717-7988
Email ryuta@tohoku.ac.jp

Public contact
Name of contact person
1st name Kawata
Middle name
Last name Yuriko
Organization Tohoku University
Division name Tohoku University Institute of Development, Aging and Cancer applied brain science research
Zip code 980-8575
Address Sendai City Aoba-ku Seiryocho 4-1
TEL 022-717-7988
Homepage URL
Email natashakawata@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Institute of Development, Aging and Cancer applied brain science research
Institute
Department

Funding Source
Organization Nothing
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee Tohoku University Graduate School of Medicine
Address Seiryoncho Aoba-ku, Sendai Miyagi Prefecture 2-1
Tel 022-717-8007
Email med-kenkyo@grp.tohoku.ac.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
2019 Year 06 Month 25 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 50
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
2019 Year 05 Month 08 Day
Date of IRB
2019 Year 05 Month 27 Day
Anticipated trial start date
2019 Year 07 Month 01 Day
Last follow-up date
2020 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 18 Day
Last modified on
2021 Year 01 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042271

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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