UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041229 |
|---|---|
| Receipt number | R000046839 |
| Scientific Title | Rapid objective audiometry using EEG |
| Date of disclosure of the study information | 2020/07/28 |
| Last modified on | 2022/04/18 12:31:48 |
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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
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
skan@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046839
