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Pediatric/Adolescent WatchPAT 400 Reliability Pilot Study
Sponsor: Milton S. Hershey Medical Center
Summary
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.
Official title: Diagnostic Accuracy and Inter-Rater Reliability of the WatchPAT® 400 Home Sleep Apnea Testing Device Compared to Attended In-Laboratory Polysomnography in Children and Adolescents Aged 6-18 Years
Key Details
Gender
All
Age Range
6 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2026-12-01
Completion Date
2028-12-01
Last Updated
2026-10-05
Healthy Volunteers
No
Interventions
WatchPAT 400
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.
Locations (1)
Penn State Hershey Medical Center
Hummelstown, Pennsylvania, United States