Study on the Accuracy of the WearME System for Monitoring Lung Function and Activity in Adults with COPD

What this Trial Is About

Researchers are evaluating the WearME systems effectiveness in monitoring the severity and respiratory function of people with Chronic Obstructive Pulmonary Disease COPD. This observational study compares the systems measurements with standard clinical assessments such as spirometry and capnography. The study aims to provide innovative technology access to underserved patients in low-income, rural, and diverse ethnic communities in the Mid-Atlantic region to help detect early signs of worsening lung function and reduce hospital readmissions. Participants will wear the WearME device during a data collection session lasting 145 minutes. The study will assess parameters including forced expiratory volume FEV1, forced vital capacity FVC, respiratory rate, heart rate, inspiratory to expiratory IE ratio, spinal range of motion ROM, and activity levels. The WearME-Pro systems measurements will be compared to gold standard FDA-cleared devices used in clinical practice. Up to 128 COPD patients will be grouped by severity using the GOLD standard and monitored simultaneously with the WearME-Basic and WearME-Pro systems. During the study, participants will wear the device while undergoing reference testing with standard medical devices. Researchers will evaluate the agreement between WearME-Pro and standard devices for lung function measures and validate the WearME-Basic system for vital signs and activity accuracy. The primary outcome focuses on the agreement of FEV1FVC measurements, with secondary outcomes assessing respiration rate, heart rate, IE ratio, and ROM accuracy. The total participation involves a single data collection period and associated clinical assessments, with monitoring conducted within six months of study start.

Effectiveness of the WearME System for COPD Severity and Respiratory Function