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

What this Trial Is About

Researchers are investigating how a wearable near-infrared spectroscopy (NIRS) device compares to traditional sleep study methods in children with and without obstructive sleep apnea (OSA). The study focuses on measuring oxygen levels in the brain and limbs of children aged 3 to 12 years to better understand the effects of pediatric OSA on oxygen saturation during sleep. This observational study is carried out in collaboration with the Sleep and Neurodevelopment Service at the NIH Clinical Center and involves no changes to patient care. Participants are divided into two groups: children without OSA (NORM group) who have one overnight sleep study visit, and children with OSA (OSA group) who have two overnight visits, one before and one after treatment. During the visits, children undergo a physical exam, medical history review, and a sleep study with electroencephalography (EEG) using electrodes placed on the head and a gauze cap to hold them in place. Soft silicon NIRS probes are placed on the forehead and arm to measure cerebral and peripheral oxygen levels while children follow their normal bedtime routine with a parent staying overnight. Throughout the study, researchers assess multiple physiological signals including cerebral and peripheral oxygen saturation and respiratory flow during sleep. The main outcomes include baseline cerebral and peripheral oxygen saturation. The OSA group repeats the sleep study 2 weeks to 12 months after starting treatment to compare oxygenation changes. Data collection also includes reviewing medical records and previous NIH study participation. The study is designed to observe and characterize oxygen level dynamics without altering standard care, with participation lasting through the follow-up period after treatment initiation.

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