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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023624
Receipt No. R000027207
Scientific Title Comprehensive evaluation of vestibular function in the peripheral vestibular disorders
Date of disclosure of the study information 2016/08/20
Last modified on 2019/08/23

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Basic information
Public title Comprehensive evaluation of vestibular function in the peripheral vestibular disorders
Acronym Comprehensive evaluation of vestibular function in the peripheral vestibular disorders
Scientific Title Comprehensive evaluation of vestibular function in the peripheral vestibular disorders
Scientific Title:Acronym Comprehensive evaluation of vestibular function in the peripheral vestibular disorders
Region
Japan

Condition
Condition vestibular disorders
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of vestibular function by using video head impulse test (vHIT) and vestibular myogenic potential (VEMP)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The results of vHIT
Key secondary outcomes The results of VEMP

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 video head impulse test
Interventions/Control_2 vestibular evoked myogenic potenstial
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 peripheral vestibular disorders and normal control
Key exclusion criteria patients with cervical spine disease
Target sample size 26

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keishi Fujiwara
Organization Hokkaido University Hospital
Division name Department ot Otolaryngology, Head and Neck Surgery
Zip code
Address N14W6, kita-ku, Sapporo, Hokkaido, Japan
TEL 011-716-1161
Email boron700@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keishi Fujiwara
Organization Hokkaido University Hospital
Division name Department ot Otolaryngology, Head and Neck Surgery
Zip code
Address N14W6, kita-ku, Sapporo, Hokkaido, Japan
TEL 011-716-1161
Homepage URL
Email boron700@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

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
Address
Tel
Email

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 北海道大学病院(北海道)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 20 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
2016 Year 08 Month 11 Day
Date of IRB
2016 Year 08 Month 30 Day
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
2018 Year 03 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
2016 Year 08 Month 14 Day
Last modified on
2019 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027207

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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