WearME-Pro Phase II: Remote Use Usability and Longitudinal Validation Study (Patch Form Factor).

This Phase II investigation evaluates the safety, usability, and clinical performance of the WearME-Pro patch system for remote monitoring of adults with COPD in a home-use environment. The protocol includes two components: (A) a \~1-month summative usability/human factors evaluation of the WearME-Pro patch, mobile app, and clinician dashboard; and (B) a 10-month longitudinal home-use study comparing WearME-Pro predicted lung function metrics (FEV1, FVC, FEV1/FVC) to an FDA-cleared handheld spirometer, with an adherence target of ≥85%. WearME-Pro outputs are investigational and are not used to direct clinical decisions during the study.

NCT Number	NCT07430605
Lead Sponsor	LASARRUS Clinic and Research Center Collaborators: Johns Hopkins University, Tidalhealth, National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
Conditions	Chronic Obstructive Pulmonary Disease (COPD)
Enrollment	82 participants
Start Date	2026-05-01
Primary Completion	2028-04-28 (estimated)
Study Completion	2028-04-28 (estimated)
Updated on ClinicalTrials.gov	2026-02-24