WatchPAT 400 for Obstructive Sleep Apnea
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Ahmet Tanritanir, MD
Principal Investigator
Penn State College of Medicine / Penn State Health
Are You a Good Fit for This Trial?
This trial is for children and teens ages 6-18 who are being checked for possible obstructive sleep apnea. Participants must already be scheduled for an overnight sleep study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Simultaneous Overnight Recording
Participants undergo simultaneous overnight recording with both attended, technician-monitored polysomnography (PSG) and the WatchPAT 400 device.
Follow-up
Participants are monitored for safety and effectiveness after the overnight recording.
What Are the Treatments Tested in This Trial?
Trial Overview
The study tests if the WatchPAT 400, a wearable device with a finger sensor, wrist unit, and chest patch, gives similar results to the standard overnight sleep study in detecting sleep apnea in kids and teens.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All enrolled participants receive this single study arm. During their already-scheduled, clinically indicated overnight polysomnogram (PSG), participants simultaneously wear the WatchPAT 400 device (finger probe, wrist unit, and adhesive chest sensor patch) for the same overnight recording. The PSG is scored by one study physician, blinded to the WatchPAT results, for standard clinical care; the WatchPAT recording is independently scored by a second study physician, blinded to the PSG results, for research comparison purposes only. No randomization, dose, or treatment assignment is involved.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Milton S. Hershey Medical Center
Lead Sponsor
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