UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058951 |
|---|---|
| Receipt number | R000067416 |
| Scientific Title | Real-time quantitative measurement of the degree of visually induced motion sickness using sensor devices embedded in a VR-HMD |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2025/09/01 11:14:52 |
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Basic information
Public title
Measurement of visually induced motion sickness in operations using a VR-HMD
Acronym
Measurement of visually induced motion sickness using a VR-HMD
Scientific Title
Real-time quantitative measurement of the degree of visually induced motion sickness using sensor devices embedded in a VR-HMD
Scientific Title:Acronym
Real-time VIMS measurement using a VR-HMD
Region
| Japan |
Condition
Condition
Motion sickness
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation on how to quantitatively measure the degree of visually induced motion sickness
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective measurement results using simulator sickness questionnaire (SSQ), heart-rate-variability (HRV) analysis based data, data obtained by sensor devices embedded in a VR-HMD (pupil position, pupil diameter, gaze vector), and results obtained through multivariate analysis on the abovementioned data
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Viewing VR motion pictures
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects with decision-making capacity
Key exclusion criteria
Subjects under 40 years old for excluding the effect of disequilibrium of aging.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Yamashita |
Organization
Saitama Medical University
Division name
Faculty of Health and Medical Care
Zip code
3501241
Address
1397-1 Yamane, Hidaka-shi, Saitama 350-1241, Japan
TEL
+81-42-984-4451
tak_yama@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Yamashita |
Organization
Saitama Medical University
Division name
Faculty of Health and Medical Care
Zip code
3501241
Address
1397-1 Yamane, Hidaka-shi, Saitama 350-1241, Japan
TEL
+81-42-984-4451
Homepage URL
tak_yama@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical 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
Institutional Review Board, Saitama Medical University
Address
38 Moro Hongo, Moroyama-cho, Iruma-gun, Saitama 350-0495
Tel
+81-49-276-2143
rinri@saitama-med.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
| 2026 | Year | 04 | 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 | 05 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 20 | 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 | 09 | Month | 01 | Day |
Last modified on
| 2025 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067416
