Tokyo, Oct. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063308) titled 'A study comparing the home sleep test device Nightgraf with overnight in-hospital polysomnography in people with suspected sleep apnea' on Oct. 16.

Study Type: Observational

Primary Sponsor: Institute - Shunkai Social Medical Corporation Inoue Hospital

Condition: Condition - Sleep-related breathing disorders (including suspected obstructive sleep apnea) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To verify the equivalence of sleep stage scoring, arousal events and respiratory events between the home PSG device Nightgraf and polysomnography (PSG) recorded simultaneously in patients with sleep-related breathing disorders, and to develop a deep neural network-based automatic scoring program for sleep stages, arousals and respiratory events specific to Nightgraf. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Aged 18 years or older at the time of consent 2) Suspected of having sleep-related breathing disorders, including obstructive sleep apnea, based on out-of-center sleep testing (OCST), pulse oximetry, interview, physical findings or clinical symptoms 3) Able to undergo simultaneous recording with PSG and Nightgraf 4) Provided written informed consent to participate in this study Key exclusion criteria - 1) Younger than 18 years 2) Difficulty wearing the Nightgraf electrodes or sensors due to skin disease, allergy, injury or other reasons 3) Judged ineligible by the principal investigator or sub-investigators for any other reason Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 27 Day Date of IRB - 2026 Year 07 Month 27 Day Anticipated trial start date - 2026 Year 11 Month 01 Day Last follow-up date - 2027 Year 10 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072466

Disclaimer: Curated by HT Syndication.