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

Launched by ITAMAR-MEDICAL, ISRAEL · Oct 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the WP, which includes a finger probe and chest sensor, to see how well it can detect sleep disorders compared to a standard method known as PSG (polysomnography). Participants will wear the WP device while also undergoing a PSG sleep study at a sleep clinic. This is important because identifying sleep disorders accurately can help improve treatment and overall health.

To be eligible for the study, participants need to be between 12 and 99 years old and should be able to understand and sign a consent form, or their parents can sign for those under 18. They should also be suspected of having sleep disorders or related health issues. However, people with certain conditions, like a permanent pacemaker or finger deformities that make it hard to use the sensor, cannot participate. If you join the study, you'll help researchers learn more about sleep disorders and how to better diagnose them in the future.

Gender

ALL

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.