Clinical trial Recruiting at 3 sites Observational Ages 12 to 99

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 typeObservational
Ages12 Years to 99 Years
SexAll
Enrollment600 (estimated)
SponsorItamar-Medical, Israel
Industry-sponsored
Locations3 sites (Baltimore, Maryland and 2 other locations)
StatusRecruiting
StartedSeptember 19, 2022
Main results expectedOctober 1, 2025
Study endsOctober 1, 2025
Registry record updatedAugust 22, 2025
Trial IDNCT06093633 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.