UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028776