UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059823 |
|---|---|
| Receipt number | R000068393 |
| Scientific Title | Quantitative Evaluation of Otolith and Gravity Perception Function Using Visually-Induced Tilt Illusion |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/11/18 19:57:27 |
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Basic information
Public title
Quantitative Evaluation of Otolith and Gravity Perception Function Using Visually-Induced Tilt Illusion
Acronym
Quantitative Evaluation of Otolith and Gravity Perception Function Using Visually-Induced Tilt Illusion
Scientific Title
Quantitative Evaluation of Otolith and Gravity Perception Function Using Visually-Induced Tilt Illusion
Scientific Title:Acronym
Quantitative Evaluation of Otolith and Gravity Perception Function Using Visually-Induced Tilt Illusion
Region
| Japan |
Condition
Condition
Healthy control, cases with PPPD
Classification by specialty
| Oto-rhino-laryngology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The presence or absence of centrifugal eye movement changes due to alterations in gravity perception will be verified by comparing tilted visual backgrounds presented via a HeadMounted Display that either induce or fail to induce gravity perception. This will allow for the quantification of the sense of dizziness at the spatial orientation level independent of peripheral vestibular function. Furthermore, we will investigate the potential for quantifying gravity perception function in patients with Persistent PosturalPerceptual Dizziness who complain of persistent unsteadiness resulting from increased visual dependence in spatial orientation formation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ocular torsion
Key secondary outcomes
sense of tilt
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Research participants will wear VR goggles. Inside the goggles, backgrounds with defined verticality (such as buildings) and backgrounds without defined verticality (such as outer space) will be displayed. These backgrounds will be tilted, and the resulting torsional eye rotation angle (or ocular counter-roll) will be measured. The tilt angles will be 60, 90, 120degrees.The eye movements will be digitized and recorded in real-time.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adult subjects (with no history of dizziness, unsteadiness, or otologic disease) and PPPD patients.
Key exclusion criteria
Under 18
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Tsutsumi |
Organization
Institute of Science Tokyo
Division name
Department of OtoRhinoLaryngology
Zip code
113-8510
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5303
tsutsumi.oto@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Tsutsumi |
Organization
Institute of Science Tokyo
Division name
Department of OtoRhinoLaryngology
Zip code
113-8510
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5303
Homepage URL
tsutsumi.oto@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Institute of Science Tokyo
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Science Tokyo, Bioethics Center
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo, Japan
Tel
03-5803-4547
rinri.adm@tmd.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | 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
| 2025 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2030 | 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
| 2025 | Year | 11 | Month | 19 | Day |
Last modified on
| 2025 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068393
