UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015613 |
|---|---|
| Receipt number | R000018145 |
| Scientific Title | Prognostic factors of hearing loss and auditoty abnormal sensation |
| Date of disclosure of the study information | 2014/11/05 |
| Last modified on | 2019/11/20 21:22:58 |
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Basic information
Public title
Prognostic factors of hearing loss and auditoty abnormal sensation
Acronym
Hearing loss and auditory abnormal sensation
Scientific Title
Prognostic factors of hearing loss and auditoty abnormal sensation
Scientific Title:Acronym
Hearing loss and auditory abnormal sensation
Region
| Japan |
Condition
Condition
hearing loss, tinnitus, hyperacusis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify prognostic factors of hearing loss and auditory abnormal sensation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hearing outcome (pure tone hearing threshold and speech discrimination score) and severity of auditory abnormal sensation (results of psychoacoustic test and questionnaires)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
all the patients of which chief complaints are hearing loss or auditory abnormal sensation
Key exclusion criteria
patients who refuse to be included in the study
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Ogawa |
Organization
Keio University School of Medicine
Division name
Department of Otolaryngology
Zip code
1608582
Address
35 Shinanomachi Shinjuku, Tokyo
TEL
03-5363-3827
ogawak@a5.keio.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Oishi |
Organization
Keio University School of Medicine
Division name
Department of Otolaryngology
Zip code
1608582
Address
35 Shinanomachi Shinjuku
TEL
03-5363-3827
Homepage URL
oishi_naoki@z5.keio.jp
Sponsor or person
Institute
Keio University School of Medicine, Department of Otolaryngology
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku
Tel
0333531211
oishin@keio.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
| 2014 | Year | 11 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Hearing and vestibular test results, and imaging
Management information
Registered date
| 2014 | Year | 11 | Month | 05 | Day |
Last modified on
| 2019 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018145
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
