Milton S. Hershey Medical Center
The goal of this clinical trial is to learn whether a newer sleep-testing device gives results that closely match the standard overnight sleep study, in children and adolescents ages 6-18 who are being evaluated for possible sleep apnea. The main questions it aims to answer are: Does the new device (WatchPAT 400) give breathing and oxygen level results that agree with the standard overnight sleep study (polysomnography)? How reliably can two doctors, each looking at only one test's results, arrive at similar conclusions about a child's sleep apnea? Participants will: Have their regular, already-scheduled overnight sleep study performed exactly as usual Wear the WatchPAT 400 device (a small sensor on one finger, a wrist unit, and one adhesive patch on the chest) at the same time, during that same night Have both sets of results reviewed separately by two different study doctors Researchers will compare the results from the WatchPAT 400 device to the results from the standard sleep study to see how closely they agree, and how well the new device performs at detecting sleep apnea in children and teenagers.
This is a prospective, single-center, blinded, within-subject diagnostic-accuracy pilot study. Each participant undergoes simultaneous overnight recording with both attended, technician-monitored polysomnography (PSG) - the clinically indicated standard-of-care test they are already scheduled for - and the WatchPAT 400 device, on the same single night. This within-subject design was chosen specifically to eliminate night-to-night physiological variability as a confounder in the agreement analysis, a limitation common to studies that compare sequential rather than simultaneous recordings. Obst…
Inclusion Criteria: Age 6-18 years at time of enrollment Referred to the sleep clinic for snoring, with clinical scheduling for a technician-attended in-laboratory polysomnogram (PSG) for suspected obstructive sleep apnea Parent-completed Obstructive Sleep Apnea-18 (OSA-18) quality-of-life questionnaire score ≥60 (moderate-to-high probability of pediatric OSA) Neurodevelopmentally typical: no diagnosed intellectual disability, autism spectrum disorder, or neuromuscular/craniofacial syndrome affecting sleep or limb use Parent/legal guardian able and willing to provide written informed consent…
A peripheral arterial tonometry (PAT)-based home sleep apnea testing device (Itamar Medical/ZOLL Itamar; FDA 510(k) K250460) consisting of a finger probe, wrist-worn recording unit, and adhesive chest sensor patch. The device is worn overnight, simultaneously with standard polysomnography, to generate an apnea-hypopnea index, respiratory disturbance index, sleep-stage estimates, and, in this device generation, a central apnea index and hypoxic burden measure, for comparison against polysomnography results.