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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
Who can join
Ages 12 to 99 · All sexes
Full eligibility 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.
About the study
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.
Sponsor: Itamar-Medical, Israel · Participants: 600 · Started: Sep 19, 2022
Contact the study team
- Ravit Roytman · Phone: 00972545456819
Official record on ClinicalTrials.gov — NCT06093633
Locations in the U.S.
| Maryland | Johns Hopkins Bayview Asthma and Allergy Center, Baltimore University of Maryland St. Joseph Medical Group, Pulmonary Care & Sleep Medicine, Towson |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.