UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000042271