WearME-Pro Phase II: Remote Use Usability and Longitudinal Validation Study (Patch Form Factor)
LASARRUS Clinic and Research Center
Summary
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.
Description
WearME-Pro is a wearable, non-invasive physiological monitoring platform with two identical sensor modules, a patient-facing mobile application, and an optional clinician dashboard. For longitudinal use, the sensor modules are inserted into an adhesive patch retainer intended for prolonged skin contact (target up to \~28 days continuous wear per retainer; patch replacement per IFU/study procedures). The patch remains on the skin continuously between scheduled sessions; the mobile app initiates daily recording windows (typically totaling \~30-180 minutes/day), and sensors remain in low-power mo…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 21 years or older, either sex. * Diagnosed with COPD per GOLD criteria (GOLD 2025): post-bronchodilator FEV1/FVC \< 0.70; stratified by post-bronchodilator FEV1% predicted (severity strata). * On stable maintenance therapy for at least 2 months (no COPD medication class changes or dose escalations). * Current, former, or never smoker (smoking history collected but not an eligibility requirement). * Able to perform activities of daily living and complete study procedures (e.g., sit upright and perform spirometry maneuvers). * Able and willing to provide informed conse…
Interventions
- DeviceWearME-Pro Patch System
Wearable non-invasive monitoring platform with two sensor modules, mobile app, and optional clinician dashboard; patch retainer supports continuous wear up to \~28 days per retainer; scheduled daily recording windows typically \~30-180 min/day.
- DeviceFDA-cleared handheld spirometer (reference comparator)
Daily handheld spirometry collected at home to provide reference standards for paired comparisons with WearME-Pro predicted lung function (FEV1, FVC, FEV1/FVC).
- DeviceCardea SOLO ECG patch (optional subset; exploratory HR reference)
Optional FDA-cleared single-use ECG patch worn up to 24-48 hours at Baseline and End of Study for exploratory heart-rate reference comparisons.
Locations (3)
- Johns HopkinsBaltimore, Maryland
- LASARRUS Clinic and Research Center Inc.Baltimore, Maryland
- TidalHealthSalisbury, Maryland