Wearable Near-Infrared Spectroscopy Monitoring Study in Children Ages 3 to 12 With and Without Obstructive Sleep Apnea

What this Trial Is About

Pediatric obstructive sleep apnea OSA causes airway blockage leading to breathing pauses during sleep, which can have long-term effects on children. This research aims to evaluate a wearable near-infrared spectroscopy NIRS monitoring device compared to traditional sleep study techniques in children aged 3 to 12 with and without OSA. The study focuses on oxygen levels in the brain and limbs during sleep and apnea events. Participants include two groups children without OSA NORM group who will have one overnight sleep study visit, and children with OSA OSA group who will have two overnight visits, one before and another 2 weeks to 12 months after starting treatment. During visits, children undergo a physical exam, medical history review, and polysomnography with EEG electrodes and NIRS probes placed on the forehead and arm to measure cerebral and peripheral oxygen saturation. Throughout the study, parents stay overnight with their children as they follow normal bedtime routines. Researchers collect data on brain and tissue oxygen levels, respiratory flow, and sleep stage dynamics. The primary outcome measures focus on cerebral and peripheral oxygen saturation at baseline and during sleep apnea events. The study is observational, with no changes to patient care, and aims to better understand physiological changes in pediatric OSA over time.

Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea