UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057330 |
|---|---|
| Receipt number | R000065531 |
| Scientific Title | Effect of Subthreshold Vibration Stimulation to the Mastoid Process on Visually induced motion sickness. |
| Date of disclosure of the study information | 2025/04/10 |
| Last modified on | 2025/03/18 16:34:17 |
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Basic information
Public title
Effect of Subthreshold Vibration Stimulation to the Mastoid Process on Visually induced motion sickness.
Acronym
Effect of Vibration Stimulation on VR Sickness
Scientific Title
Effect of Subthreshold Vibration Stimulation to the Mastoid Process on Visually induced motion sickness.
Scientific Title:Acronym
Effect of Vibration Stimulation on VR Sickness
Region
| Japan |
Condition
Condition
Healthy young adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to analyze VR sickness symptoms and the effects of vibration by providing above-threshold and sub-threshold vibration stimuli during VR viewing, and verifying both subjective and objective aspects using questionnaires, heart rate sensors, and salivary amylase
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-report questionnaire, Electrocardiogram, Salivary amylase
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Subthreshold vibration stimulation
Interventions/Control_2
Above-threshold vibration stimulation
Interventions/Control_3
Control
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
| 22 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy young volunteers who volunteered to participate in the study
Key exclusion criteria
People with serious neurological conditions, joint problems, or visual/hearing disabilities
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Maeda |
Organization
International University of Health and Welfare
Division name
School of Health Sciences
Zip code
2508588
Address
1-2-25 Shiroyama, Odawara, Kanagawa, Japan
TEL
0465216671
ymaeda10@gmail.com
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Maeda |
Organization
International University of Health and Welfare
Division name
School of Health Sciences
Zip code
2508588
Address
1-2-25 Shiroyama, Odawara, Kanagawa, Japan
TEL
0465216671
Homepage URL
y.maeda@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare, School of Health Sciences, Yusuke Maeda
Institute
Department
Personal name
Funding Source
Organization
none
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
International University of Health and Welfare Ceitified Review Board
Address
4-1-26 Akasaka MInato-ward, Tokyo, Japan
Tel
03-5574-3900
rinri-shinsa-system@iuhw.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 | 04 | Month | 10 | 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 | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2035 | 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 | 03 | Month | 18 | Day |
Last modified on
| 2025 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065531
