Clinical Trial: Prospective validation of automatic sleep staging using an EEG-based depth of anesthesia monitor and an open-source sleep staging toolbox (Japan)

Tokyo, Oct. 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059550) titled 'Prospective validation of automatic sleep staging using an EEG-based depth of anesthesia monitor and an open-source sleep staging toolbox' on Oct. 28.

Study Type: Observational

Primary Sponsor: Institute - Fukushima Medical University

Condition: Condition - Sleep disorders Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to evaluate the accuracy of automatic sleep staging using electroencephalographic (EEG) signals obtained from an EEG-based depth of anesthesia monitor, SedLine(R), and analyzed with an open-source automatic sleep staging toolbox, YASA. The accuracy will be assessed by comparing the YASA-based sleep staging results with those obtained from polysomnography (PSG). In patients suspected of having sleep disorders who undergo PSG, SedLine will be applied simultaneously. EEG signals collected from SedLine will be analyzed for sleep stages using the YASA algorithm. The PSG-based sleep staging results will then be compared with those derived from SedLine. The primary outcome will be the level of agreement between the two sleep staging methods, expressed as Cohen's kappa coefficient. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Adults aged 18 years or older at the time of obtaining informed consent 2. Patients scheduled to undergo polysomnography Key exclusion criteria - 1. Patients who are unable or unwilling to provide informed consent 2. Patients with central nervous system disorders (e.g., cognitive impairment, epilepsy, brain tumour, or psychiatric disorders) 3. Patients who are highly likely to be unable to remain still during the examination Target Size - 7

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 27 Day Date of IRB - 2025 Year 10 Month 27 Day Anticipated trial start date - 2025 Year 10 Month 29 Day Last follow-up date - 2030 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068115

Disclaimer: Curated by HT Syndication.