Tokyo, Feb. 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060714) titled 'Study on Task Performance Under Low-Illuminance Conditions With Controlled Illuminance and Color Temperature' on Feb. 23.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Placebo
Primary Sponsor:
Institute - KANEKA CORPORATION
Condition:
Condition - Healthy volunteers
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To compare the effects of light environments with general LED lighting, OLED lighting on Work Performance
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Visit 1: OLED (150 lux) followed by LED (150 lux)
Visit 2: LED (300 lux) followed by OLED (300 lux)
Visit 3: OLED (500 lux) followed by LED (500 lux)
Visit 4: LED (750 lux) followed by OLED (750 lux)
Interventions/Control_2 - Visit 1: OLED (300 lux) followed by LED (300 lux)
Visit 2: LED (500 lux) followed by OLED (500 lux)
Visit 3: OLED (750 lux) followed by LED (750 lux)
Visit 4: LED (150 lux) followed by OLED (150 lux)
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - 1) Healthy Japanese males aged 18 to 50 years old
2) Individuals with a habitual sleep duration of 7 hours or longer
3) Individuals with the ability to visit the designated university at the specified date and time
4) Individuals with written informed consent to participate in this study
Key exclusion criteria - 1) Individuals with Any current medical treatment
2) Individuals with current or past psychiatric diseases
3) Individuals with any eye diseases
4) Individuals with injuries or disabilities that interfere with undergoing the examinations
5) Individuals with an inability to refrain from consuming Foods for Specified Health Uses (FOSHU), Foods with Function Claims, or other so-called health foods during the study period
6) Individuals with current participation in another clinical study, or participation in another clinical study within one month prior to the date of informed consent
7) Individuals with plans to participate in another study during the study period
8) Individuals with an inability or unwillingness to comply with the instructions of the principal investigator, study representative,or sub-investigators
9) Individuals with an inability to comply with participant management requirements during the study period (Section 4.9)
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 22 Day
Date of IRB - 2025 Year 09 Month 22 Day
Anticipated trial start date - 2026 Year 02 Month 23 Day
Last follow-up date - 2026 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069464
Disclaimer: Curated by HT Syndication.