Tokyo, May 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061429) titled 'Study on Reducing the Effects of Morning Sunlight on Circadian Rhythms in Night-Shift Drivers' on May 1.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Non-randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - S'UIMIN Inc.

Condition: Condition - healthy person Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to investigate whether drivers who regularly work night shifts in the transportation industry can improve their daytime sleep after returning home by wearing tinted sunglasses during driving after sunrise, compared to wearing blue light-blocking glasses. We will conduct objective sleep assessments using a simple EEG device and subjective sleep evaluations using a post-wake-up sleep questionnaire. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Group A: For each participant, the study period spans 14 days, from Sunday through the following Saturday. During the first week, participants will wear tinted sunglasses from Tuesday through Saturday during periods that include driving after sunrise and driving home. For the four days from Tuesday to Friday of the first week, objective sleep assessments using an EEG device, as well as subjective sleep assessments using a pre-sleep questionnaire and a post-awakening sleep quality questionnaire, will be conducted during daytime naps after returning home. During the second week, blue light-blocking glasses will be worn under the same conditions, and the same sleep assessments will be conducted. Interventions/Control_2 - Group B: For each participant, the study period spans 14 days, from Sunday through the following Saturday. During the first week, participants will wear blue light-blocking glasses from Tuesday through Saturday during periods that include driving after sunrise and driving home. For the four days from Tuesday to Friday of the first week, objective sleep assessments using an EEG device, as well as subjective sleep assessments using a pre-sleep questionnaire and a post-wake-up sleep quality questionnaire, will be conducted for daytime naps taken after returning home. During the second week, participants will wear light-blocking sunglasses under the same conditions, and the same sleep assessments will be conducted.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - Participants must meet all of the following criteria: 1.Drivers who regularly work a five-days-on, two-days-off schedule and engage in night-shift driving work for five consecutive nights from Monday night to Friday night. 2.Individuals who can report their usual bedtime and wake-up time for each day from Sunday to Saturday, and whose calculated time in bed is not less than 5 hours. 3.Individuals who can comply with mild sleep control from the Sunday before sleep measurement until the end of sleep measurement, namely going to bed within +/-2 hours of their reported bedtime and waking up within +/-2 hours of their reported wake-up time. 4.Individuals who can avoid alcohol consumption and intake of caffeinated beverages after 4 hours before bedtime on electroencephalography measurement days. 5.Individuals who can sleep alone in a futon or bed during the study period. Sleeping in the same room with others is acceptable if each person uses independent bedding. 6.Individuals who understand the study contents and provide written informed consent voluntarily. Key exclusion criteria - Individuals who meet any of the following criteria will be excluded: 1.Individuals currently visiting a medical institution for treatment or with a current medical history. 2.Individuals who regularly use medications, excluding vitamins. 3.Individuals who cannot discontinue supplements, foods with functional claims, health foods, or similar products related to sleep during the study period. 4.Individuals who habitually consume excessive alcohol. Excessive alcohol consumption is defined as drinking the equivalent of two go of sake or more, five times per week. 5.Individuals who are currently participating in, or planning to participate in, another clinical trial at the start of this study. 6.Individuals judged by the principal investigator to be inappropriate as study participants. Target Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 13 Day Date of IRB - 2026 Year 04 Month 30 Day Anticipated trial start date - 2026 Year 05 Month 07 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=R000070289

Disclaimer: Curated by HT Syndication.