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

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.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DEVICE

Cardea 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.

DEVICE

WearME-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.

DEVICE

FDA-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).

Sponsors & Collaborators

• Johns Hopkins University

  collaborator OTHER

• Tidalhealth

  collaborator UNKNOWN

• National Institutes of Health (NIH)

  collaborator NIH

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• LASARRUS Clinic and Research Center

  lead INDUSTRY

Principal Investigators

• Edward Chen, MD · Johns Hopkins University

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-01

Primary Completion

2028-04-28

Completion

2028-04-28

FDA Device

Yes

Countries

• United States

Study Locations