Abstract:Study Objectives: To evaluate the agreement between the millimeter-wave radar-based device and polysomnography (PSG) in diagnosis of obstructive sleep apnea (OSA) and classification of sleep stage in children. Methods: 281 children, aged 1 to 18 years, who underwent sleep monitoring between September and November 2023 at the Sleep Center of Beijing Children's Hospital, Capital Medical University, were recruited in the study. All enrolled children underwent sleep monitoring by PSG and the millimeter-wave radar-based device, QSA600, simultaneously. QSA600 recordings were automatically analyzed using a deep learning model meanwhile the PSG data was manually scored. Results: The Obstructive Apnea-Hypopnea Index (OAHI) obtained from QSA600 and PSG demonstrates a high level of agreement with an intraclass correlation coefficient of 0.945 (95% CI: 0.93 to 0.96). Bland-Altman analysis indicates that the mean difference of OAHI between QSA600 and PSG is -0.10 events/h (95% CI: -11.15 to 10.96). The deep learning model evaluated through cross-validation showed good sensitivity (81.8%, 84.3% and 89.7%) and specificity (90.5%, 95.3% and 97.1%) values for diagnosing children with OAHI>1, OAHI>5 and OAHI>10. The area under the receiver operating characteristic curve is 0.923, 0.955 and 0.988, respectively. For sleep stage classification, the model achieved Kappa coefficients of 0.854, 0.781, and 0.734, with corresponding overall accuracies of 95.0%, 84.8%, and 79.7% for Wake-sleep classification, Wake-REM-Light-Deep classification, and Wake-REM-N1-N2 N3 classification, respectively. Conclusions: QSA600 has demonstrated high agreement with PSG in diagnosing OSA and performing sleep staging in children. The device is portable, low-load and suitable for follow up and long-term pediatric sleep assessment.