UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042332
Receipt number R000048325
Scientific Title Exploratory research to establish a test method for assessing auditory attention disorder
Date of disclosure of the study information 2020/11/05
Last modified on 2024/03/01 23:04:30

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Basic information

Public title

Exploratory research to establish a test method for assessing auditory attention disorder

Acronym

Exploratory research to establish a test method for assessing auditory attention disorder

Scientific Title

Exploratory research to establish a test method for assessing auditory attention disorder

Scientific Title:Acronym

Exploratory research to establish a test method for assessing auditory attention disorder

Region

Japan


Condition

Condition

auditory processing disorder
tinnitus

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The basic data necessary to visualize the impaired auditory attention mechanism will be accumulated exploratively, and the test method and test conditions to assess the insufficiency of the auditory attention mechanism will be established.

Basic objectives2

Others

Basic objectives -Others

assessment of pathophysiology

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Percent correct for frequency discrimination task

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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



Eligibility

Age-lower limit

15 years-old <=

Age-upper limit

40 years-old >

Gender

Male and Female

Key inclusion criteria

1) normal subjects with no history of ear disease or neurological / neurological disease2) Patients diagnosed as auditory iprocessing disorder
3) Tinnitus patients with a THI score of 40 or higher

Key exclusion criteria

(1) Nonmal subject
1) Those with a history of ear disease
2) Those with a history of mental illness3) Those with a history of peripheral or central nervous system diseases
4) Those who are pregnant or may become pregnant
5) In addition, those who are judged by the principal investigator or coordinator to be inappropriate as subjects
(2) Auditory processing disorder / tinnitus patients
1) Those who are pregnant or may become pregnant
2) In addition, those who are judged by the principal investigator or coordinator to be inappropriate as subjects

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Tetsuaki
Middle name
Last name Kawase

Organization

Tohoku University

Division name

Graduate School of Biomedical Engineering

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-7303

Email

kawase@orl.med.tohoku.ac.jp


Public contact

Name of contact person

1st name Tetsuaki
Middle name
Last name Kawase

Organization

Tohoku University

Division name

Graduate School of Biomedical Engineering

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-7303

Homepage URL


Email

kawase@orl.med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

the Ministry of Education, Culture, Sports, Science and Technology-Japan

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

Tohoku University Graduate School of Medicine Ethics Committee

Address

2-1 Seiryo-machi, Aoba-ku, Sendai

Tel

0227178007

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

2020 Year 11 Month 05 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


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

Open public recruiting

Date of protocol fixation

2020 Year 10 Month 26 Day

Date of IRB

2020 Year 11 Month 04 Day

Anticipated trial start date

2020 Year 11 Month 15 Day

Last follow-up date

2025 Year 10 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observational study on evaluation of auditory attention in normal subjects and patient groups (patients with auditory processing disorder and tinnitus patients)


Management information

Registered date

2020 Year 11 Month 03 Day

Last modified on

2024 Year 03 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048325


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name