Pediatric/Adolescent WatchPAT 400 Reliability Pilot Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorMilton S. Hershey Medical Center
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 6-18 years at time of enrollment
Referred to the sleep clinic for Sleep disordered breathing symptoms.
Scheduling for a technician-attended in-laboratory polysomnogram (PSG)
Obstructive Sleep Apnea-18 (OSA-18) questionnaire score ≥60
Disqualifiers
Known peripheral vascular disease, Raynaud phenomenon, or other condition affecting digital arterial pulsation
Current use of alpha-adrenergic blocking agents or other medications known to significantly affect peripheral vasomotor tone
Permanent cardiac pacemaker, atrial fibrillation, or other clinically significant arrhythmia at the time of study
Known neurodevelopmental disability (Trisomy 21, autism spectrum disorder, or similar), as above
Trial design
Design model
Single group
Treatments tested in this trial
WatchPAT 400
DeviceA 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.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: WatchPAT 400 + Standard PSG (Simultaneous)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Agreement Between WatchPAT 400-Derived Apnea-Hypopnea Index (pAHI) and Polysomnography-Derived Apnea-Hypopnea Index (AHI)
Agreement between the WatchPAT 400 pAHI and the polysomnography (PSG)-derived AHI, both obtained from the same simultaneous overnight recording, assessed using the intraclass correlation coefficient (two-way mixed effects, absolute agreement) with 95% confidence interval, and Bland-Altman limits of agreement (mean bias and 95% limits of agreement, in events/hour).
Time frame
Single overnight recording (one night)Secondary outcomes
1
Sensitivity and Specificity of WatchPAT 400 for Detection of Obstructive Sleep Apne
Sensitivity, specificity, positive predictive value, and negative predictive value of the WatchPAT 400 pAHI for detecting obstructive sleep apnea and classifying its severity (none, mild, moderate, severe), using polysomnography-derived AHI as the reference standard, calculated at standard clinical thresholds (AHI ≥1, ≥5, and ≥10 events/hour).
Time frame
Single overnight recording (one night)Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: