UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055314 |
|---|---|
| Receipt number | R000063213 |
| Scientific Title | Research study on vestibular feedback using artificial Vestibular Stabilization program |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2026/02/27 05:32:08 |
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Basic information
Public title
The effect of image stabilization on dizziness
Acronym
The effect of image stabilization on dizziness
Scientific Title
Research study on vestibular feedback using artificial Vestibular Stabilization program
Scientific Title:Acronym
Research study on vestibular feedback using artificial Vestibular Stabilization program
Region
| Japan |
Condition
Condition
vertigo
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the effect of vision on vestibular feedback
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensation of dizziness immediately after conducting rotational stimulus
Key secondary outcomes
Heart rate, pupil diameter, slow phase eye velocity, visual acuity, postural sway immediately after conducting rotational stimulus
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Visual stabilization during rotational stimulus
(two times, 30 seconds each)
Interventions/Control_2
No visual stabilization during rotational stimulus
(two times, 30 seconds each)
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 subjects
Key exclusion criteria
Past medical history of dizziness, central nervous disease or musculoskeletal weakness
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Tsutsumi |
Organization
Tokyo Medical and Dental University
Division name
Department of Otorhinolaryngology
Zip code
113-8519
Address
Yushima 1-5-45, Bunkyo-ku , Tokyo 113-8519, Japan
TEL
03-5803-5303
tsutsumi.oto@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Ayame |
| Middle name | |
| Last name | Yamazaki |
Organization
Tokyo Medical and Dental University
Division name
Department of Otorhinolaryngology
Zip code
113-8519
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo 113-8519, Japan
TEL
03-5803-5308
Homepage URL
ayamoto@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
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
Ethical review committee of Tokyo Medical and Dental University
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo 113-0034, Japan
Tel
03-3813-6111
syomu1.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
東京医科歯科大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | 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
| 2024 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2024 | Year | 08 | Month | 23 | Day |
Last modified on
| 2026 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063213
