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WatchPAT 400 home sleep test compared with overnight sleep study in children

Compares WatchPAT 400 to sleep lab tests for childhood sleep apnea.

Key facts

Who runs it
Milton S. Hershey Medical Center
Where
Hummelstown, United StatesSee the site
Trial code
Registry title
Pediatric/Adolescent WatchPAT 400 Reliability Pilot Study
Status
Not yet recruiting
People taking part
35 people, planned
Starts
1 Dec 2026
Expected to end
1 Dec 2028
Type of study
Interventional
Treatments tested
  • WatchPAT 400
Record updated
5 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teens aged 6-18 who were sent to a sleep clinic for possible sleep apnea, a condition where breathing stops and starts during sleep. They must already be booked for an overnight sleep study in a sleep lab.

Age
6 to 18 years
Sex
All sexes
Disease stage
Breathing problems during sleep, already booked for an overnight sleep study in a lab with a technician present. The score on the OSA-18 sleep questionnaire must be 60 or higher.
Earlier treatment
People currently taking alpha-adrenergic blocking agents, or other medicines that strongly affect blood vessels in the hands and feet, cannot join.
Biomarker or test result
OSA-18 questionnaire score of 60 or higher

Main reasons for not taking part

  • A known developmental disability of the brain, such as Trisomy 21 or autism spectrum disorder
  • Blood vessel disease in the arms or legs, Raynaud phenomenon, or other problems with blood flow in the fingers
  • A permanent heart pacemaker, atrial fibrillation, or another serious irregular heartbeat
  • An amputation, deformity or injury of the fingers that stops the finger sensor from being placed
  • An allergy to latex or to sticky patches, or pregnancy

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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
  • No neurodevelopmentally disability
  • Parent/legal guardian able and willing to provide written informed consent (participants who are 18 years old provide their own consent); participant able to provide age-appropriate assent where applicable
  • Finger, hand, and chest anatomy able to accommodate the WatchPAT 400 finger probe, wrist unit, and chest sensor patch

Who cannot take part

  • Current use of alpha-adrenergic blocking agents or other medications known to significantly affect peripheral vasomotor tone
  • Prior amputation, digital deformity, or injury to the fingers precluding probe placement
  • Known peripheral vascular disease, Raynaud phenomenon, or other condition affecting digital arterial pulsation
  • 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
  • Known latex or adhesive allergy relevant to device sensor materials
  • Inability or unwillingness to tolerate simultaneous placement of both the PSG and WatchPAT sensors
  • Pregnancy, for adolescent participants where applicable

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 6 and 18 years old?

Where in United States

  • Penn State Hershey Medical CenterHummelstown, United StatesContact: Ahmet Tanritanir, MDNo longer taking part

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

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.

The group in the trial

  • WatchPAT 400 + Standard PSG (Simultaneous)Treatment being tested

    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.

    Treatment: WatchPAT 400

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
WatchPAT 400 home sleep test compared with overnight sleep study in childrenGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT07851402, who can take part
Record updated
5 October 2026