A Prospective Study to Evaluate the WatchPAT in Comparison to Polysomnography (PSG) Gold Standard in Patients Suspected of Sleep Disorders
Itamar-Medical, Israel
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.
Description
Subjects suspected of having sleep disorders who are referred to a sleep study will be screened for potential participation in the study, according to the inclusion and exclusion criteria. Additionally, patients with comorbidities associated with central sleep apnea may be referred from cardiology related divisions, and screened for participation in the study. Recruited patients will be asked to sign an informed consent form. Subject demographic and medical information will be acquired from the subject himself and/or from the subject's medical chart and will be recorded on the appropriate case…
Eligibility
- Age range
- 12–99 years
- Sex
- All
- Healthy volunteers
- No
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.
Locations (3)
- Johns Hopkins Bayview Asthma and Allergy CenterBaltimore, Maryland
- University of Maryland St. Joseph Medical Group, Pulmonary Care & Sleep MedicineTowson, Maryland
- Tel-Aviv Medical CenterTel Aviv