Pediatric/Adolescent WatchPAT 400 Reliability Pilot Study

Part of paid clinical trials in Hummelstown, Pennsylvania.

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT07851402
Status
Not Yet Recruiting

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Conditions

  • Obstructive Sleep Apnea
  • Pediatric Sleep Disordered Breathing

Eligibility Criteria

Sex
ALL
Age
6 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • WatchPAT 400 — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Oct 1, 2026
Start date
Dec 1, 2026
Status verified
Sep 2026
Primary completion
Nov 30, 2027
Completion
Dec 1, 2028

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: WatchPAT 400 + Standard PSG (Simultaneous)
    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.

Primary Outcome Measure

Agreement Between WatchPAT 400-Derived Apnea-Hypopnea Index (pAHI) and Polysomnography-Derived Apnea-Hypopnea Index (AHI) [ Time Frame: Single overnight recording (one night) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Penn State Hershey Medical CenterHummelstownPennsylvania17036-

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Penn State Hershey Medical Center· Hummelstown, PA

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