RecruitingNCT06093633

A Prospective Study to Evaluate the WP in Comparison to PSG in Patients Suspected of Sleep Disorders

A Prospective Study to Evaluate the WatchPAT in Comparison to Polysomnography (PSG) Gold Standard in Patients Suspected of Sleep Disorders


Sponsor

Itamar-Medical, Israel

Enrollment

600 participants

Start Date

Sep 19, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

The current study is a prospective blinded study to collect data regarding the performance of the WP device in detecting sleep disorders. For that purpose, the WP with finger probe and chest sensor will be worn by the subject simultaneous to PSG in a sleep study at the clinical sleep lab. A PSG system will be recording the PSG data.


Eligibility

Min Age: 12 YearsMax Age: 99 Years

Inclusion Criteria3

  • 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 Criteria2

  • Permanent pacemaker: atrial pacing or VVI without sinus rhythm.
  • Finger deformity that precludes adequate sensor appliance.

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Locations(3)

Johns Hopkins Bayview Asthma and Allergy Center

Baltimore, Maryland, United States

University of Maryland St. Joseph Medical Group, Pulmonary Care & Sleep Medicine

Towson, Maryland, United States

Tel-Aviv Medical Center

Tel Aviv, Israel

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NCT06093633


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