UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037099 |
|---|---|
| Receipt number | 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 10:12:17 |
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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
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
natashakawata@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Institute of Development, Aging and Cancer applied brain science research
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042271
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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