Tokyo, May 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061524) titled 'Supporting Aviator Using Physiological Data in the Future Cockpit Environment - An Exploratory Study on Effective Indicators for Evaluating Aircraft Piloting Proficiency' on May 11.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Aviation Safety and Aeromedical Reserch Group
Condition:
Condition - Healthy Adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Exploratory investigetion of effective physiological indicators for evaluating manual handling skills of novice aviators
Basic objectives2 - Efficacy
Intervention:
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
Eligibility:
Age-lower limit - 20
years-old
Gender - Male
Key inclusion criteria - Japanese citizen can understand Japanese language
Individuals with uncorrected visual acuity of 0.1 or higher
Individuals who consent to the removal of makeup and other substances necessary for electrode placement
Individuals who consent to the application of EEG gel to the scalp
Key exclusion criteria - Individuals whose eyes have been operated on in the past
Individuals with cataracts, amblyopia, strabismus, ptosis, astigmatism, or severe hyperopia
Individuals whose pupils are constantly dilated due to medical treatment or other reasons
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 undergone neurosurgery in the past
Individuals with a history of paroxysmal disorders or epilepsy
Individuals who have experienced an allergic reaction with electrodes or EEG gel
Target Size - 12
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 15 Day
Date of IRB - 2026 Year 05 Month 11 Day
Anticipated trial start date - 2026 Year 05 Month 15 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070128
Disclaimer: Curated by HT Syndication.