UMIN-ICDS Clinical Trial

Public title

Preliminary Study on Elucidating the Mechanisms and Establishing Assessment Criteria for Listening Difficulties

Acronym

Preliminary Study on Elucidating the Mechanisms and Establishing Assessment Criteria for Listening Difficulties

Scientific Title

Preliminary Study on Elucidating the Mechanisms and Establishing Assessment Criteria for Listening Difficulties

Scientific Title:Acronym

Preliminary Study on Elucidating the Mechanisms and Establishing Assessment Criteria for Listening Difficulties

Region

Japan

Condition

Listening Difficulties

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In our study, we conducted exploratory psychoacoustic and neurophysiological tests on both individuals with normal hearing and those with hearing difficulties in a setting that simulates everyday environments, where audiovisual stimuli were presented. The results will serve as foundational data for future efforts to elucidate the pathophysiology of hearing difficulties and establish intervention and support methods.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Auditory Evoked Responses/Event-Related Potentials: Amplitude

Key secondary outcomes

Auditory Evoked Responses/Event-Related Potentials: Latency

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Participants performed a dichotic listening task in which a target stimulus sound was presented to one ear and a distractor stimulus sound to the opposite ear, while a distractor stimulus video was presented via a video display device according to the experimental condition. Using the speech discrimination accuracy for the target stimulus sound and auditory evoked potentials (N100, ASSR)/ event-related potentials (P300, mismatch negativity) obtained from the measurements. We will exploratively examine conditions in which attention to the target stimulus sound is disrupted, differences in measurement results between hearing volunteers and individuals with hearing difficulties (patient volunteers), and the presence or absence of additive effects associated with multisensory integration of the attention-distracting stimulus.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1 No history of ear disorders or neurological conditions
2 Average hearing level in both ears is less than 25 dB HL on puretone audiometry
3 Age 18 years or older, but under 40 years of age at the time of enrollment
4 Gender Open to both men and women
5 Participants who have provided written informed

Key exclusion criteria

1 Individuals with a history of ear disorders
2 Individuals with a history of peripheral or central nervous system disorders
3 Any other individuals deemed unsuitable as study participants by the principal investigator or a co-investigator

Target sample size

60

Name of lead principal investigator

1st name	Katori
Middle name
Last name	Yukio

Organization

Tohoku University

Division name

Department of Otolaryngology-Head and Neck Surgery

Zip code

980-8574

Address

1-1 Seiryo-cho Aoba-ku Sendaishi

TEL

022-717-7304

Email

shunsuke.takai.d7@tohoku.ac.jp

Name of contact person

1st name	Shunsuke
Middle name
Last name	Takai

Organization

Tohoku University

Division name

Department of Otolaryngology-Head and Neck Surgery

Zip code

980-8574

Address

1-1 Seiryo-cho Aoba-ku Sendaishi

TEL

022-717-7304

Homepage URL

Email

shunsuke.takai.d7@tohoku.ac.jp

Institute

Tohoku University

Institute

Department

Personal name

Organization

Monbu kagaku sho

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Tohoku University

Address

1-1 Seiryo-cho Aoba-ku Sendaishi

Tel

022-717-7304

Email

shunsuke.takai.d7@tohoku.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

07

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

04

Month

22

Day

Date of IRB

2026

Year

05

Month

27

Day

Anticipated trial start date

2026

Year

07

Month

01

Day

Last follow-up date

2029

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

07

Month

11

Day

Last modified on

2026

Year

07

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071192