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Pediatric/Adolescent WatchPAT 400 Reliability Pilot Study

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Eligibility criteria shortened, about 10 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07851402
Lead Sponsor Milton S. Hershey Medical Center
Conditions
(from sponsor)		 Pediatric Sleep Disordered Breathing, Obstructive Sleep Apnea
Related terms Sleep Apnea, Obstructive
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov