Evaluating a new device for detecting sleep disorders compared to traditional methods
Official title: A Prospective Study to Evaluate the WatchPAT in Comparison to Polysomnography (PSG) Gold Standard in Patients Suspected of Sleep Disorders
Run by Itamar-Medical, Israel · NCT06093633 · Data updated 2026-11-12
This study is testing a new device called WatchPAT to see if it can detect sleep disorders as well as traditional sleep tests do.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 12 Years to 99 Years |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Itamar-Medical, Israel Industry-sponsored |
| Locations | 3 sites (Baltimore, Maryland and 2 other locations) |
| Status | Recruiting |
| Started | September 19, 2022 |
| Main results expected | October 1, 2025 |
| Study ends | October 1, 2025 |
| Registry record updated | August 22, 2025 |
| Trial ID | NCT06093633 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals aged 12-99 who are suspected of having sleep disorders or have comorbidities related to central sleep apnea.
✕Probably not a fit
Patients with permanent pacemakers or finger deformities that prevent proper sensor application may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the performance of the WatchPAT device in detecting sleep disorders by comparing its results with those obtained from polysomnography (PSG). Participants suspected of having sleep disorders will wear the WatchPAT device alongside a full night PSG recording in a clinical sleep lab. Data will be collected on patient demographics and medical history, and the PSG will be scored manually while the WatchPAT analysis will be conducted automatically. The study seeks to determine the effectiveness of the WatchPAT device in diagnosing sleep disorders.
Why it matters
Potential benefit: If successful, this study could provide a more accessible and efficient method for diagnosing sleep disorders.
How similar studies have gone: Other studies have shown promise in using similar ambulatory devices for sleep disorder detection, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 12-99 * Subjects that are able to read understand and sign the informed consent form of the study or by parents of subjects that are less than 18 years of age that are referred to undergo an overnight sleep study in the clinical sleep laboratory * Subjects suspected of having sleep disorders or with comorbidities relevant to central sleep apnea. Exclusion Criteria: * Permanent pacemaker: atrial pacing or VVI without sinus rhythm. * Finger deformity that precludes adequate sensor appliance.
Where it's running
-
Johns Hopkins Bayview Asthma and Allergy Center
Baltimore, Maryland, United States Recruiting -
University of Maryland St. Joseph Medical Group, Pulmonary Care & Sleep Medicine
Towson, Maryland, United States Recruiting -
Tel-Aviv Medical Center
Tel Aviv, Israel Recruiting
Study contacts
- Principal investigator: Rivi Tauman, Prof, — Tel Aviv Medical Center
- Study coordinator: Ravit Roytman
- Email: ravit.lusky@zoll.com
- Phone: 00972545456819
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.