Tokyo, Nov. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059527) titled 'Examination of the effects of sleep fragmentation on autonomic nervous system function' on Nov. 10.

Study Type: Interventional

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

Primary Sponsor: Institute - National Center of Neurology and Psychiatry

Condition: Condition - Healthy individuals Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective is to evaluate the effects of sleep fragmentation (repeated sleep interruptions) on autonomic nervous activity during sleep and during the daytime, as well as on attention, cognitive function, emotional function, the endocrine system, and the inflammatory response. Basic objectives2 - Others

Intervention: Interventions/Control_1 - In Group 1, the first intervention is conducted under the sleep fragmentation condition, forced awakening approximately every hour for 3-5 minutes during nighttime sleep. An interval of at least 7 days is maintained between conditions. The second intervention is conducted under the sleep restriction condition, limiting sleep duration to 5 hours. Interventions/Control_2 - In Group 2, the first intervention is conducted under the sleep restriction condition, limiting sleep duration to 5 hours. An interval of at least 7 days is maintained between conditions. The second intervention is conducted under the sleep fragmentation condition, forced awakening approximately every hour for 3-5 minutes during nighttime sleep.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1)Female participants who regularly monitor their menstrual cycle and are available during the follicular phase 2)Individuals from whom written informed consent can be obtained Key exclusion criteria - 1)Individuals with conditions likely to be exacerbated by experimental stressors, including insomnia (self-reported) 2)Individuals with arrhythmia, pacemaker implantation, or heart disease 3)Individuals taking medications that affect the autonomic nervous system function (such as beta-blockers, antidepressants, or steroids) 4)Individuals taking sleeping pills or other medications that affect sleep 5)Individuals deemed unsuitable at the discretion of the principal investigator Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 03 Day Anticipated trial start date - 2025 Year 11 Month 10 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067895

Disclaimer: Curated by HT Syndication.