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

ClinicalTrials.gov ID

NCT07430605

Lead Sponsor

LASARRUS Clinic and Research CenterINDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

82Estimated

Last Update Posted

Feb 24, 2026Actual

Start Date

May 1, 2026Estimated

Primary Completion Date

Apr 28, 2028Estimated

Completion Date

Apr 28, 2028Estimated

Official Title

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

Brief 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.

Detailed 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 mode outside those windows. In the longitudinal component, participants complete daily WearME-Pro sessions plus daily handheld spirometry to enable paired comparisons. A subset of participants may optionally wear an FDA-cleared ECG patch (Cardea SOLO) for 24-48 hours at Baseline and End of Study as an exploratory heart-rate reference. Participants also complete daily symptom reporting and periodic questionnaires, with check-ins per the protocol schedule.

• Chronic Obstructive Pulmonary Disease (COPD)

• WearME-Pro Patch System
• FDA-cleared handheld spirometer (reference comparator)
• Cardea SOLO ECG patch (optional subset; exploratory HR reference)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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 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.

Exclusion Criteria:

• 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.

Primary Purpose

Other

Allocation

Non-Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

LASARRUS Clinic and Research CenterINDUSTRY

Collaborators

Johns Hopkins UniversityOTHER

TidalhealthUNKNOWN

National Institutes of Health (NIH)NIH

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

Robert.Chasse@tidalhealth.org410-543-7722

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