Tokyo, Dec. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060029) titled 'An Investigation into the Variability of Sleep-Wake Pattern Disruptions in Circadian Rhythm Sleep-Wake Disorders' on Dec. 9.

Study Type: Observational

Primary Sponsor: Institute - Fujita Health University

Condition: Condition - Circadian Rhythm Sleep-Wake Disorders Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Delayed Sleep-Wake Phase Disorder (DSWPD), a major subtype of Circadian Rhythm Sleep-Wake Disorders (CRSWDs), causes difficulty aligning internal rhythms with the 24-hour schedule, leading to delayed sleep onset, difficulty awakening, and severe social maladaptation in adolescents and young adults. Traditionally, DSWPD was thought to involve a delayed melatonin rhythm along with the sleep-wake phase. However, recent studies report that nearly half of patients show normal melatonin timing. We have observed variable sleep duration and unusually long circadian periods in patients with rhythm misalignment. This study retrospectively examines sleep diaries or actigraphy for psychiatric comorbidities and mood variability, and prospectively monitors sleep-wake patterns, melatonin rhythms, and estimated core body temperature rhythms. We aim to clarify concordance or discrepancy between behavioral and central clock rhythms and their relationship with slow-wave sleep profiles. Basic objectives2 - Others

Eligibility: Age-lower limit - 12 years-old

Gender - Male and Female Key inclusion criteria - The study will include patients attending the Sleep Clinic of the Department of Psychiatry at Fujita Health University who have CRSWDs or psychiatric disorders presenting with disturbed sleep-wake rhythms, and who have shown either fluctuations in sleep duration during the course of illness or circadian sleep-wake cycles longer than 24 hours. For the prospective study, participants must provide written informed consent after receiving a full explanation and demonstrating sufficient understanding. At the time of consent, patients must be aged 12 years or older (at least elementary school graduate) and younger than 70 years, and participation must be entirely voluntary. Key exclusion criteria - 1. Patients presenting with severe suicidal ideation 2. Patients deemed inappropriate by the principal investigator or co-investigators for any other reason Target Size - 100

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 12 Month 09 Day Date of IRB - 2025 Year 10 Month 27 Day Anticipated trial start date - 2025 Year 12 Month 09 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068653

Disclaimer: Curated by HT Syndication.