UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025011
Receipt number R000028776
Scientific Title Development of objective assessments for the auditory processing disorders.
Date of disclosure of the study information 2017/02/01
Last modified on 2020/05/31 10:47:13

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Basic information

Public title

Development of objective assessments for the auditory processing disorders.

Acronym

Development of objective assessments for the auditory processing disorders.

Scientific Title

Development of objective assessments for the auditory processing disorders.

Scientific Title:Acronym

Development of objective assessments for the auditory processing disorders.

Region

Japan


Condition

Condition

Auditory processing disorders

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examination of the efficient electrophysiological audiometry for the auditory processing disorders.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Electrophysiological audiometry
Evoked potential inspection
Event related potential

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

7 years-old <=

Age-upper limit

30 years-old >

Gender

Male and Female

Key inclusion criteria

Patient Group:The objects who have hearing problems.
Control Group:The objects who have no hearing problems.

Key exclusion criteria

The objects who have diagnosed as organic hearing loss.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name Iwai

Organization

Kansai Medical University

Division name

Department of Otolaryngology-Head and Neck Surgery

Zip code

573-1191

Address

2-3-1 Shinmachi, Hirakata-City, Osaka, Japan.

TEL

072-804-0101

Email

iwai@hirakata.kmu.ac.jp


Public contact

Name of contact person

1st name Michiko
Middle name
Last name Ashitani

Organization

Shiga University

Division name

Department of Education

Zip code

520-0862

Address

2-5-1 Hiratsu, Otsu-city, Shiga, Japan.

TEL

077-537-7769

Homepage URL


Email

amichiko@edu.shiga-u.ac.jp


Sponsor or person

Institute

Kansai Medical Univesity

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

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

Kansai Medical University Research Ethics Committee

Address

2-3-1 Shinmachi, Hirakata-City, Osaka, Japan.

Tel

072-804-2551

Email

rinriirb@hirakata.kmu.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

2017 Year 02 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

5

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

Main results already published

Date of protocol fixation

2016 Year 11 Month 25 Day

Date of IRB

2017 Year 01 Month 16 Day

Anticipated trial start date

2018 Year 10 Month 01 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

In the developed system, we could record the P300 by using the 67-S word tone. P300 was measured when the SN ratio was 10 dB and 5 dB, but disappeared at 0 dB.


Management information

Registered date

2016 Year 11 Month 27 Day

Last modified on

2020 Year 05 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028776


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name