UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060754 |
|---|---|
| Receipt number | R000069444 |
| Scientific Title | Supporting Aviator Using Physiological Data in the Future Cockpit Environment: A Pilot Study |
| Date of disclosure of the study information | 2026/02/27 |
| Last modified on | 2026/02/26 13:17:34 |
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Basic information
Public title
An Exploratory Study on Effective Indicators for Evaluating Aircraft Piloting Proficiency
Acronym
An Exploratory Study on Effective Indicators for Evaluating Aircraft Piloting Proficiency
Scientific Title
Supporting Aviator Using Physiological Data in the Future Cockpit Environment: A Pilot Study
Scientific Title:Acronym
Supporting Aviator Using Physiological Data in the Future Cockpit Environment: A Pilot Study
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploratory investigetion of effective physiological indicators for evaluating manual handling skills of novice aviators
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electroencephalogram (Event-related potential)
Key secondary outcomes
Task performance
Input to aircraft
Eye-tracking data
Heart rate and heart rate variability
Respiration
Subjective evaluation (NASA-TLX(J))
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Day 1
Simulated flight (practice)
Day 2
Simulated flight (easy task, difficult task)
Presentation of auditory stimuli (probe stimuli) during resting state and simulated flight
Day 3
Simulated flight (practice)
Day 4
Same as Day 2
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals who agree to participate in the four-day experiment
Individuals with normal vision or corrected-to-normal vision with lenses ranging from +3.0D to -8.0D
Key exclusion criteria
Abnormalities on the scalp, the face, and the chest where electrodes will be attached
Prone to motion sickness from video games and movie images
Individuals who have experienced an allergic reaction with electrodes or EEG gel
Target sample size
12
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 | Yuji |
| Middle name | |
| Last name | Iino |
Organization
Aviation Safety and Aeromedical Research Group
Division name
Aviation Safety Research Division
Zip code
3501324
Address
2-3 Inariyama, Saayama-shi, Saitama, Japan
TEL
04-2953-6131
Homepage URL
IINOd1q@inet.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
Japanese Governmental office
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 | 02 | Month | 27 | 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 | 15 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2027 | 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 | 02 | Month | 26 | Day |
Last modified on
| 2026 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069444
