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

Abstract

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 (PSG_RDI), and Sunrise RDI (Sr_RDI). Performance of Sr_RDI was determined via ROC curves evaluating the device sensitivity and specificity at PSG_OAHI ≥ 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 Sr_RDI and PSG_RDI. Areas under the ROC curves of Sr_RDI 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 PSG_OAHI ≥ 1, PSG_OAHI ≥ 5, or PSG_ OAHI ≥ 10, respectively. Conclusion MM automated analysis shows significant promise to diagnose moderate‐to‐severe pediatric OSA.

Pediatric pulmonology year in review 2022: Sleep medicine

“…This device may be convenient and promising as a home-based modality, providing a simplified diagnostic approach for pediatric sleep apnea, however, this will need additional validation to thoroughly evaluate its diagnostic accuracy in unattended home settings. 27 These studies demonstrate the growing interest in using at-home devices for monitoring pediatric sleep disorders, particularly in the context of SDB and OSA. While telehealth-supported level 2 PSG has shown promise as a lower-cost and more accessible alternative to traditional level 1 PSG, further validation studies may be necessary before it can be considered a standard diagnostic tool.…”

“…The study found that the Sunrise MM device offered a balanced accuracy of 85% and an area under the receiver operating characteristic curve (ROC AUC) of 0.9 for AHI > 5 events per hour, making this device a viable option for the detection of children with moderate to severe OSA. This device may be convenient and promising as a home‐based modality, providing a simplified diagnostic approach for pediatric sleep apnea, however, this will need additional validation to thoroughly evaluate its diagnostic accuracy in unattended home settings 27 . These studies demonstrate the growing interest in using at‐home devices for monitoring pediatric sleep disorders, particularly in the context of SDB and OSA.…”

“…While level 2 testing seems diagnostically feasible and promising, level 4 at‐home testing (or unattended home pulse oximetry) seems to be suboptimal for the diagnosis of SDB based on the results published Isaka et al, 26 where they found that a level 4 home testing with a cutoff of 6.3 events/h had a sensitivity, specificity, and accuracy of 64.4%, 70.3%, and 67.5%, respectively, to detect a PSG AHI of >10 events/h. Another study by Martinot et al 27 evaluated the clinical validation of a mandibular movement (MM) signal‐based system for the diagnosis of pediatric OSA. The study found that the Sunrise MM device offered a balanced accuracy of 85% and an area under the receiver operating characteristic curve (ROC AUC) of 0.9 for AHI > 5 events per hour, making this device a viable option for the detection of children with moderate to severe OSA.…”

Analysis of mandibular jaw movements to assess ventilatory support management of children with obstructive sleep apnea syndrome treated with positive airway pressure therapies

“…12 Another study using this technology coupled with automated analysis conducted in the pediatric population also demonstrated a good agreement between MJM and the polysomnographic results. 13 The PSG is also the reference technique for the evaluation of treatment efficacy and residual events in children treated by continuous positive airway pressure (CPAP) or noninvasive ventilation (NIV). The management of OSA in children is essentially based on the treatment of the underlying cause of obstruction (tonsillectomy or maxilla facial surgery, orthodontic management, allergy management, weight loss in case of obesity).…”

Outpatient screening for obstructive sleep apnea-hypopnea syndrome: what place for the Sunrise device?

“…importantes que dans la population adulte. Ce diagnostic dérivant de l'analyse du MM se montre favorable dans les formes modérées à sévères, ne montrant qu'une sensibilité et une spécificité médiocres dans les formes légères9 . D'autres études essaient de pousser l'algorithme plus loin, dont l'étude de Le-Dong et al (2021) qui étudie le lien entre le MM et les différents stades du sommeil, avec des résultats prometteurs 10 .…”