UMIN-CTR Clinical Trial

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
Email	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
Email	iwashin-tky@umin.ac.jp

Sponsor
Institute	University of Tokyo Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042310