UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000051580
Receipt number R000058841
Scientific Title The relationship between speech perception training and neural oscillations: a study using perceptual tasks of nonnative sounds (Korean) for native Japanese listeners and EEG
Date of disclosure of the study information 2023/07/11
Last modified on 2025/01/22 22:47:34

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Basic information

Public title

The relationship between listening training and neural activity: a study using listening tasks of nonnative sounds (Korean) for native Japanese listeners and EEG

Acronym

A study on the relationship between listening training and neural activity

Scientific Title

The relationship between speech perception training and neural oscillations: a study using perceptual tasks of nonnative sounds (Korean) for native Japanese listeners and EEG

Scientific Title:Acronym

A study on the relationship between speech perception training and neural oscillations

Region

Japan


Condition

Condition

Healthy control

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to obtain insights into the effects of perceptual training on neural oscillations by comparing EEG before and after perceptual training while distinguishing nonnative speech sounds in healthy individuals.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The power and coherence of neural oscillations for the fundamental frequency of speech sounds

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

A group of native Japanese speakers. Identification and discrimination tasks are performed for four days without explanations of the acoustic differences among Korean sounds.

Interventions/Control_2

A group of native Japanese speakers. Identification and discrimination tasks are performed for four days with explanations of the acoustic differences among Korean sounds.

Interventions/Control_3

A group of native Korean speakers. No training.

Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

18 to 65-year-old men and women whose native language is either Japanese or Korean

Key exclusion criteria

1. If the individual's native language based on self-reported information is not only Japanese or only Korean
2. If there is a caregiver, based on self-reported information, who is a nonnative speaker of the individual's native language
3. If there is a history of concussion or severe head injury
4. If there is a history of neurological or psychiatric disorders
5. If there is a history of psychiatric disorders in a first-degree relative (parent, sibling, child) based on self-reported information
6. If there is a history of using psychotropic medications (mood stabilizers, antipsychotics, etc.)
7. If there is alcohol dependence or substance dependence
8. If there is an uncorrectable hearing or visual impairment

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Shogo
Middle name
Last name Hirano

Organization

Kyushu University Hospital

Division name

Department of Neuropsychiatry

Zip code

812-8582

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka

TEL

092-642-5625

Email

nouseiri.ku@gmail.com


Public contact

Name of contact person

1st name Yubin
Middle name
Last name Sung

Organization

Kyushu University Hospital

Division name

Department of Neuropsychiatry

Zip code

812-8582

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka

TEL

092-642-5625

Homepage URL


Email

nouseiri.ku@gmail.com


Sponsor or person

Institute

Kyushu University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committees of Kyushu University Hospital and Medical Institutions

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka

Tel

092-642-5082

Email

byskenkyu@jimu.kyushu-u.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

2023 Year 07 Month 11 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

49

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

No longer recruiting

Date of protocol fixation

2023 Year 07 Month 11 Day

Date of IRB

2023 Year 06 Month 07 Day

Anticipated trial start date

2023 Year 07 Month 11 Day

Last follow-up date

2028 Year 06 Month 04 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2023 Year 07 Month 11 Day

Last modified on

2025 Year 01 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058841