Clinical validation of a mandibular movement signal based system for the diagnosis of pediatric sleep apnea

BACKGROUND: Given the high prevalence and risk for outcomes associated with pediatric obstructive sleep apnea (OSA), there is a need for simplified diagnostic approaches. A prospective study in 140 children undergoing in-laboratory polysomnography (PSG) evaluates the accuracy of a recently developed system (Sunrise) to estimate respiratory efforts by monitoring sleep mandibular movements (MM) for the diagnosis of OSA (Sunrise™). METHODS: Diagnosis and severity were defined by an obstructive apnea/hypopnea index (OAHI) ≥ 1 (mild), ≥ 5 (moderate), and ≥ 10 events/h (severe). Agreement between PSG and Sunrise™ was assessed by Bland-Altman method comparing respiratory disturbances hourly index (RDI) (obstructive apneas, hypopneas, and respiratory effort-related arousals) during PSG (PSGRDI), and Sunrise RDI (SrRDI). Performance of SrRDI was determined via ROC curves evaluating the device sensitivity and specificity at PSGOAHI ≥ 1, 5, and 15 events/h. RESULTS: A median difference of 1. 57 events/h, 95% confidence interval: -2. 49 to 8. 11 was found between SrRDI and PSGRDI. Areas under the ROC curves of SrRDI were 0. 75 (interquartile range IQR: 0. 72-0. 78), 0. 90 (IQR: 0. 86-0. 92) and 0. 95 (IQR: 0. 90-0. 99) for detecting children with PSGOAHI ≥ 1, PSGOAHI ≥ 5, or PSG_ OAHI ≥ 10, respectively. CONCLUSION: MM automated analysis shows significant promise to diagnose moderate-to-severe pediatric OSA.