Advancing Sleep Testing for Children: In-Laboratory Validation of a Type 2 Sleep-Monitoring System Designed for Home-Based Pediatric Assessment

Background: Comprehensive Type 2 sleep-monitoring systems designed to support home-based assessment may improve access to pediatric sleep assessment while preserving evaluation of sleep architecture and respiratory events. This study evaluated the clinical performance of a wearable Type 2 sleep monitoring system compared with standard in-laboratory polysomnography in children. Methods: Children referred for overnight sleep evaluation underwent simultaneous recordings using the Dormotech wearable Type 2 system and in-laboratory polysomnography (Nox A1). Recordings were manually scored according to American Academy of Sleep Medicine guidelines. Primary outcomes were apnea-hypopnea index (AHI) and severity classification; secondary outcomes included global sleep-wake and respiratory parameters, usability, and safety. Results: Twenty-four children completed supervised in-laboratory recordings and were included in the analysis (median age, 10.5 years; 25th-75th percentiles, 8.8-13.3; 50.0% female). Median AHI was 2.2 (25th-75th percentiles, 0.9-3.4) events/h with Dormotech and 1.3 (0.6-3.6) events/h with polysomnography (p = 0.808). AHI severity classification showed high agreement (κ = 0.896), with a median Bland–-Altman paired difference (Nox - Dormotech) of -0.2 events/h and empirical 95% limits of agreement of -1.9 to 6.7 events/h. No significant differences were observed across secondary sleep or respiratory parameters. User experience was favorable, with no device-related adverse events. Conclusions: The comprehensive Type 2 system demonstrated strong agreement with in-laboratory polysomnography across respiratory and global sleep-wake measures in children. These findings demonstrate agreement under supervised laboratory conditions and provide a foundation for future studies evaluating the system’s performance in unsupervised use settings.