UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060513 |
|---|---|
| Receipt number | R000069213 |
| Scientific Title | Fundamental study on methods for detecting flight illusions and spatial disorientation, and preventing accidents (Simulation of flight illusions using virtual reality (VR) technology) |
| Date of disclosure of the study information | 2026/01/29 |
| Last modified on | 2026/01/29 16:34:50 |
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Basic information
Public title
Study on simulation methods for illusions during flight
Acronym
Study on simulation methods for illusions during flight
Scientific Title
Fundamental study on methods for detecting flight illusions and spatial disorientation, and preventing accidents (Simulation of flight illusions using virtual reality (VR) technology)
Scientific Title:Acronym
Fundamental study on methods for detecting flight illusions and spatial disorientation, and preventing accidents (Simulation of flight illusions using virtual reality (VR) technology)
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effective mithods for inducing flight illusions and spatial disorientation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Center of Gravity Position
(before, during, and after stimulation)
Key secondary outcomes
Subjective Evaluation
Task Performance
Brain Activity (Electroencephalogram, EEG)
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Galvanic Vestibular Stimulation (anode: right side), Visual Environment (Good)
Interventions/Control_2
Galvanic Vestibular Stimulation (anode: right side), Visual Environment (Degraded)
Interventions/Control_3
Galvanic Vestibular Stimulation (anode: left side), Visual Environment (Good)
Interventions/Control_4
Galvanic Vestibular Stimulation (anode: left side), Visual Environment (Degraded)
Interventions/Control_5
Galvanic Vestibular Stimulation (none), Visual Environment (Good)
Interventions/Control_6
Galvanic Vestibular Stimulation(none), Visual Environment (Degraded)
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults aged between 20 and 40 years old
Individuals with unaided or corrected visual acuity of 1.0 or higher
Individuals can bring their regularly used contact lenses
Who consent to wearing pads moistened with saline solution, applying gel to the head, and wiping these off with a towel upon leaving
Native language is Japanese
Individuals with experience using commercial flight simulators
Key exclusion criteria
Pregnant or may be pregnant women
History of migraine, paroxysmal disorders, or epilepsy
Abnormalities on the scalp where electrodes will be attached
Metal implants in the body
Electroconvulsive therapy or transcranial direct current stimulation (tDCS) is clinically contraindicated
Adverse reactions to electrical stimulation
Surgical procedures involving the brain or spinal cord
Eye surgery or ocular diseased
Ear surgery or ear diseases
Smokers
Prone to simulator sickness or screen-induced nausea
Currently taking medication
Regularly wear glasses
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yasutami |
| Middle name | |
| Last name | Otsuka |
Organization
Aviation Safety and Aeromedical Research Group
Division name
Aviation Safety Research Division
Zip code
3501324
Address
2-3 Inariyama, Sayama-shi, Saitama, Japan
TEL
04-2953-6131
OTSUKAd2w@inet.aci.mod.go.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Aiba |
Organization
Aviation Safety and Aeromedical Research Group
Division name
Aviation Safety Research Division
Zip code
3501324
Address
2-3 Inariyama, Sayama-shi, Saitama, Japan
TEL
04-2953-6131
Homepage URL
AIBAd4k@inat.aci.mod.go.jp
Sponsor or person
Institute
Aviation Safety and Aeromedical Research Group
Institute
Department
Personal name
Funding Source
Organization
Japan Air Self-Defense Force
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aviation Safety and Aeromedical Research Group Ethics Review Committee
Address
2-3 Inariyama, Sayama-shi, Saitama, Japan
Tel
04-2953-6131
KIKUKAWAz2c@inet.aci.mod.co.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 | 01 | Month | 29 | 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 | 16 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2026 | 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
| 2026 | Year | 01 | Month | 29 | Day |
Last modified on
| 2026 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069213
