UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037129 |
|---|---|
| Receipt number | R000042310 |
| Scientific Title | Epidemiological survey of bilateral vetibulopathy in Japan |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2019/06/20 21:10:40 |
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Basic information
Public title
Epidemiological survey of bilateral vetibulopathy in Japan
Acronym
Epidemiological survey of bilateral vetibulopathy in Japan
Scientific Title
Epidemiological survey of bilateral vetibulopathy in Japan
Scientific Title:Acronym
Epidemiological survey of bilateral vetibulopathy in Japan
Region
| Japan |
Condition
Condition
bilateral vestibulopathy
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the prevalence and morbidity of patients with bilateral vestibulopathy in Japan.
Basic objectives2
Others
Basic objectives -Others
To investigate the clinical characteristics of patients with bilateral vestibulopathy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To estimate the prevalence, morbidity, and clinical characteristics of patients with bilateral vestibulopathy
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Reduced or absent caloric responses in both ears.
Key exclusion criteria
None
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Iwasaki |
Organization
University of Tokyo Hospital
Division name
Department of Otolaryngology
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
+81358008665
iwashin-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Iwasaki |
Organization
University of Tokyo Hospital
Division name
Department of Otolaryngology
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
+81358008665
Homepage URL
iwashin-tky@umin.ac.jp
Sponsor or person
Institute
University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Equilibrium Society
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
+81338155411
iwashin-tky@umin.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
東京大学医学部耳鼻咽喉科
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 01 | 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
| 2019 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To mail quesitonaire to randomly chosen otolaryngologic clinics asking about patients who have bilateral vestibulopathy came to each clinic during one year.
Management information
Registered date
| 2019 | Year | 06 | Month | 20 | Day |
Last modified on
| 2019 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042310
