Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062669) titled 'A study of the post-illumination pupil response in circadian rhythm sleep-wake disorders' on Sept. 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Fujita Health University

Condition: Condition - circadian rhythm sleep-wake disorder Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To elucidate the pathophysiology of circadian rhythm sleep-wake disorders, we will assess light sensitivity using the post-illumination pupil response in patients with delayed sleep-wake phase disorder and non-24-hour sleep-wake rhythm disorder and compare the results with those of healthy controls. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Post-illumination pupil response is measured using an electronic pupillometer.

Eligibility: Age-lower limit - 12 years-old

Gender - Male and Female Key inclusion criteria - 1.Patients who provided written informed consent of their own free will after receiving a sufficient explanation of the study and fully understanding its contents. 2.Patients aged 12 years or older and younger than 70 years at the time of consent, who had completed elementary school. 3.Patients diagnosed with delayed sleep-wake phase disorder (DSWPD) or non-24-hour sleep-wake rhythm disorder (N24SWD) according to the ICSD-3 diagnostic criteria. 4.The presence or absence of comorbid psychiatric or physical disorders was not restricted. 5.No restrictions were placed on current treatment.

1.Individuals who provided written informed consent of their own free will after receiving a sufficient explanation of the study and fully understanding its contents. 2.Individuals aged 12 years or older and younger than 70 years at the time of consent, who had completed elementary school. 3.Individuals without disturbances in their sleep-wake rhythm. Key exclusion criteria - 1.Patients with severe suicidal ideation. 2.Patients judged by the principal investigator or co-investigators to be unsuitable for participation in the study.

1.Individuals who meet the diagnostic criteria for any sleep disorder or psychiatric disorder according to the ICSD-3 or DSM-5. 2.Individuals currently using psychotropic medications, such as antipsychotics, antidepressants, or hypnotics. 3.Individuals judged by the principal investigator or co-investigators to be unsuitable for participation in the study. Target Size - 100

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 08 Month 21 Day Date of IRB - 2026 Year 08 Month 19 Day Anticipated trial start date - 2026 Year 08 Month 24 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071700

Disclaimer: Curated by HT Syndication.