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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041229
Receipt No. R000046839
Scientific Title Rapid objective audiometry using EEG
Date of disclosure of the study information 2020/07/28
Last modified on 2020/07/28

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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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 03 Day
Date of IRB
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
2020 Year 07 Month 28 Day


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

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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