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Clinical Characteristics of Vestibular Orientation in Patients with Vestibular Disorders

Status Approved

First Submitted Date

2019/08/28
Registered Date

2019/09/09
Last Updated Date

2019/09/09

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0004289
Unique Protocol ID	B-1908/556-301
Public/Brief Title	Clinical Characteristics of Vestibular Orientation in Patients with Vestibular Disorders
Scientific Title	Clinical Characteristics of Vestibular Orientation in Patients with Vestibular Disorders
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	B-1908/556-301
Approval Date	2019-07-31
Institutional Review Board Name	Seoul National University Bundang Hospital Institutional Review Board
Institutional Review Board Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do
Institutional Review Board Telephone	031-787-8801
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Jeong-Yoon Choi
Title	MD, PhD
Telephone	+82-31-787-7562
Affiliation	Seoul National University Bundang Hospital
Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
Contact Person for Public Queries
Name	Hyo-Jung Kim
Title	PhD
Telephone	+82-31-787-8401
Affiliation	Seoul National University Bundang Hospital
Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
Contact Person for Updating Information
Name	Hyo-Jung Kim
Title	PhD
Telephone	+82-31-787-8401
Affiliation	Seoul National University Bundang Hospital
Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Not yet recruiting
Date of First Enrollment	2019-09-09 Anticipated
Target Number of Participant	60
Primary Completion Date	2019-12-31 , Anticipated
Study Completion Date	2020-06-30 , Anticipated
Name of Study	Seoul National University Bundang Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2019-09-09 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	National Research Foundation
Organization Type	Others
Project ID	2017R1C1B1008582

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Seoul National University Bundang Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	The human can accurately sense the motion during daily activities and estimate the head and body positions in space. The vestibular disorders could affect the estimation of motion and position. This study aims to measure subjective sensations of motion and position using 3D rotation chair in patients with various vestibular disorders.

Study Summary Information

Lay Summary

The human can accurately sense the motion during daily activities and estimate the head and body positions in space. The vestibular disorders could affect the estimation of motion and position. This study aims to measure subjective sensations of motion and position using 3D rotation chair in patients with various vestibular disorders.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Others
Time Perspective	Prospective
Target Number of Participant	60
Cohort/Group Number	2
Cohort/ Group 1	Cohort/Group Label Peripheral vestibular disorders
Cohort/ Group 1	Cohort/Group Description - Evaluation of vestibular orientation in patients with peripheral vestibular disorders. - Evaluation of vestibular orientation to measure subjective sensations quantitatively using a 3D rotary stimulator consists of position task, velocity task, and time task.
Cohort/ Group 2	Cohort/Group Label Central vestibular disorders
Cohort/ Group 2	Cohort/Group Description - Evaluation of vestibular orientation in patients with central vestibular disorders. - Evaluation of vestibular orientation to measure subjective sensations quantitatively using a 3D rotary stimulator consists of position task, velocity task, and time task.
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	During the study period, patients who visited dizziness center of seoul national university bundang hospital and diagnosed with central or peripheral vestibulopathy.
Sampling Method	Non-probability sampling
Condition(s)/Problem(s)	* (H60-H95)Diseases of the ear and mastoid process (H81.2)Vestibular neuronitis Vestibular Disease
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 18Year~No Limit
	Description 1. Signed and dated written informed consent. 2. Aged ≥18 years 3. Patients who visited dizziness center of seoul national university bundang hospital and diagnosed with central or peripheral vestibulopathy. • Peripheral vestibular disease ① Patients who have been diagnosed with unilateral vestibular neuritis and being followed up over 1 week after symptom onset. Or patients who have unilateral chronic vestibulopathy due to other vestibular disorders (tumor, Meniere's disease, ischemic vestibular injury, and trauma). ② The vHIT (video head impulse test) gain should be less than 0.8 in the lesion side. ③ Patients diagnosed with bilateral vestibulopathy. The vHIT gain should be less than 0.6 in both sides. • Central vestibular disease ① Patients diagnosed with cerebellar ataxia due to various central lesions including ischemic stroke, drug, tumor, trauma, or degeneration. ② Patients diagnosed with persistent postural-perceptual dizziness (PPPD) from known or unknown causes.
Exclusion Criteria	1. Disagree to participate in this study. 2. Subjects with cognitive impairment that may affect the vestibular function test and its results. The scores of Mini-Mental State Examination (K-MMSE) less than 24 is considered cognitive impairment. 3. Subjects with central nervous system disorders not related to peripheral and central vestibular disease. 4. Subjects have a direct relationship between subordinates and superiors or have a business relationship with the principal investigator.
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Vestibular Orientation
Timepoint	After the vestibular orientation task
Secondary Outcome(s) 1
Outcome	Neuro-otological examination
Timepoint	Before the vestibular orientation task

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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