Study Comparing the WatchPAT Device to Standard Polysomnography for Diagnosing Sleep Disorders in Patients Aged 12 to 99

What this Trial Is About

The trial investigates the WatchPAT WP devices ability to detect sleep disorders compared to the gold standard polysomnography PSG in patients suspected of sleep disorders. Participants include individuals referred for sleep studies or those with comorbidities related to central sleep apnea. The study is prospective and blinded, aiming to gather data on the WP devices performance during clinical sleep evaluations. Participants will spend one night in a clinical sleep laboratory where they will simultaneously wear the WP device with a finger probe and chest sensor while undergoing a full-night PSG recording with standard channels. The PSG data will be recorded and manually scored without access to WP data to maintain blinding, while the WP device data will be analyzed automatically. This design allows comparison between the WP device and PSG results. During the study night, demographic and medical information will be collected from participants or their medical charts. Researchers will assess the Apnea-Hypopnea Index AHI and sleep stages from one night of sleep as primary outcomes, with the Respiratory Disturbance Index RDI as a secondary outcome. The study involves a single overnight visit with no long-term follow-up, focusing on accurately measuring sleep disorder indicators through both methods.

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