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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025011
Receipt No. 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 2019/06/04

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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
Institute Kansai Medical Univesity
Institute
Department

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
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 Enrolling by invitation
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
2019 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.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


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