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

Starting soon · Not applicable

Conditions studied: Chronic Obstructive Pulmonary Disease (COPD)

In brief

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.

Key facts

Study ID

NCT07430605

Run by

LASARRUS Clinic and Research Center

People needed

82

Starts

2026-05-01

Expected to finish

2028-04-28

Last updated by the study team

2026-02-24

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 consent.
• Not currently enrolled in another investigational device study that could confound outcomes (prior WearME-Basic Phase I participation permitted if completed and not concurrent).
• Owns a compatible smartphone/tablet or willing to use a loaner device.
• Willing to wear WearME-Pro patch and perform daily handheld spirometry throughout the study.
• Optional subset only: willing to wear Cardea SOLO ECG patch for up to 24-48 hours at baseline and end of study if selected.

You may not qualify if…

• COPD exacerbation within past 6 weeks requiring systemic corticosteroids and/or antibiotics, urgent/ED visit, or hospitalization.
• Known allergy or severe skin sensitivity to medical adhesives, or dermatologic conditions at intended placement sites.
• Any condition that, in the investigator's opinion, may interfere with compliance or safety.
• Inability or unwillingness to perform daily spirometry or to use the mobile app.

Where it is running

• Johns Hopkins — Baltimore, Maryland, United States
• LASARRUS Clinic and Research Center Inc. — Baltimore, Maryland, United States
• TidalHealth — Salisbury, Maryland, United States

Full record on ClinicalTrials.gov

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