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

Study Description: This observational study will assess the sensitivity of near-infrared spectroscopy (NIRS) to hemodynamic events caused by pediatric obstructive sleep apnea (POSA). NIRS can provide a direct examination of brain oxygen saturation that traditional sleep study measurements are not able to capture and may be capable of better explaining health outcomes related to this disease. The purpose of this study is to characterize a wearable, point-of-care NIRS device that measures multiple physiological signals with a focus on cerebral and peripheral oxygenation in children with obstructive sleep apnea and to establish the relationship between traditionally measured parameters during sleep studies (polysomnography) and NIRS technologies. This study will be conducted in collaboration with the Sleep and Neurodevelopment Service at the NIH Clinical Center. Care will not be altered for any patients and this study will be purely observational with no significant risk added to any patient. We hypothesize that changes in NIRS signals of cerebral and peripheral tissue oxygenation due to apnea events will correlate with respiratory flow and oxygen saturation changes measured with PSG. Objectives: Primary Objective: Characterize cerebral oxygen saturation and peripheral tissue oxygen saturation during both normal sleep and sleep apnea events in children with respect to traditional polysomnography parameters. Exploratory Objective 1: Characterize cerebral and peripheral tissue oxygen saturation before and after POSA treatment with respect to traditional polysomnography parameters. Exploratory Objective 2: Characterize the dynamics of hemoglobin concentrations and tissue oxygenation during different sleep stages. Exploratory Objective 3: Compare dynamics of cerebral and peripheral tissue oxygen saturation during apneic events in sleep state to a breath hold while subject is awake. Endpoints: Primary Endpoint: cerebral oxygen saturation (ScO2), peripheral tissue oxygen saturation (StO2), pulsatile oxygen saturation (SpO2), respiratory flow Exploratory Endpoint 1: baseline and post-treatment ScO2, StO2, SpO2, AHI, respiratory flow Exploratory Endpoint 2: baseline and post-treatment delta hemoglobin, delta deoxyhemoglobin, cerebral oxygen saturation Exploratory Endpoint 3: ScO2, StO2 (during apnea and breath hold)