UMIN-CTR Clinical Trial

Basic information
Public title	Rapid objective audiometry using EEG
Acronym	Rapid objective audiometry using EEG
Scientific Title	Rapid objective audiometry using EEG
Scientific Title:Acronym	Rapid objective audiometry using EEG
Region	Japan

Condition
Condition	Hearing loss
Classification by specialty	Oto-rhino-laryngology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective is to validate rapid objective audiometry using EEG.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation with pure-tone audiometry
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	EEG measurement(once)
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Hearing loss patient: slight to mild hearing loss(> 70 dB) patients subject to pure-tone audiometry who are 20 years old or older. Normal hearing subject: normal hearing(> 25 dB) subjects who are 20 years old or older.
Key exclusion criteria	Hearing loss patient: patients with central nervous system diseases, patients after brain surgery, and patients who do not wish. Normal hearing subject: subjects who do not wish.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Sho Middle name Last name Kanzaki
Organization	Keio University
Division name	Department of Otorhinolaryngology, Head and Neck Surgery, School of Medicine
Zip code	160-8582
Address	Shinanomachi 35, Shinjuku-ku, Tokyo
TEL	03-5363-3827
Email	skan@keio.jp

Public contact
Name of contact person	1st name Sho Middle name Last name Kanzaki
Organization	Keio University
Division name	Department of Otorhinolaryngology, Head and Neck Surgery, School of Medicine
Zip code	160-8582
Address	Shinanomachi 35, Shinjuku-ku, Tokyo
TEL	03-5363-3827
Homepage URL
Email	skan@keio.jp

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	The University of Tokyo
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	The University of Tokyo
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Keio University
Address	Shinanomachi 35, Shinjuku-ku, Tokyo
Tel	03-3353-1211
Email	skan@keio.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	2019-0274
Org. issuing International ID_1	Keio University
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 07 Month 28 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	Completed
Date of protocol fixation	2020 Year 06 Month 03 Day
Date of IRB	2020 Year 06 Month 22 Day
Anticipated trial start date	2020 Year 08 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 07 Month 28 Day
Last modified on	2022 Year 04 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046839