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Clinical Trials in the USA / NCT07430605
Starting soon Not applicable

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

NCT07430605 · tracked via the Priya Life Science USA tracker
Sponsor
LASARRUS Clinic and Research Center
Phase
Not applicable
Started
2026-05-01
Last updated
2026-02-24

Condition(s) studied

Chronic Obstructive Pulmonary Disease (COPD)

Investigational drug(s) / intervention(s)

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

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.

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).

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.

Study 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.

Eligibility

Sex
ALL
Min age
21 Years
Max age
—
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 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 outcome measure(s)

  • Mean difference in FEV1 (L) between WearME-Pro predicted lung function and handheld spirometer — Up to 10 months (daily paired measures through Month 10)
    Agreement will be assessed using paired daily measurements of FEV1 collected during home use. The outcome will be summarized as the mean difference (WearME-Pro - handheld spirometer) in FEV1 (liters) across paired measurements.
  • Mean difference in FVC (L) between WearME-Pro predicted lung function and handheld spirometer — Up to 10 months (daily paired measures through Month 10)
    Agreement will be assessed using paired daily measurements of FVC collected during home use. The outcome will be summarized as the mean difference (WearME-Pro - handheld spirometer) in FVC (liters) across paired measurements.
  • Mean difference in FEV1/FVC (unitless ratio) between WearME-Pro predicted lung function and handheld spirometry — Up to 10 months (daily paired measures through Month 10)
    Agreement will be assessed using paired daily measurements of FEV1/FVC collected during home use. The outcome will be summarized as the mean difference (WearME-Pro - handheld spirometer) in FEV1/FVC ratio across paired measurements.
  • System Usability Scale (SUS) total score (0-100) — End of Part A (Week 4; up to 1 month)
    SUS questionnaire to assess usability for intended users in Part A (human factors/usability). Target mean SUS \> 85 over the usability period.
  • Monthly adherence rate to planned daily WearME-Pro sessions (%) — Months 1-9
    Adherence will be summarized as the percent of planned days per month with a completed WearME-Pro session with valid data, with a target of ≥85% monthly adherence during the longitudinal component.

Trial sites (3)

FacilityCityRegionStatus
Johns Hopkins Baltimore Maryland
LASARRUS Clinic and Research Center Inc. Baltimore Maryland
TidalHealth Salisbury Maryland

More LASARRUS Clinic and Research Center trials in the USA

Effectiveness of the WearME System for COPD Severity and Respiratory Function Recruiting

Other trials for the same condition

A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006) Recruiting
This After Market Study is Seeing if Dupilumab Plus Usual Standard of Care (SOC) is Better Than Usual Care Alone for Adult Participants After a Severe Chronic Obstructive Pulmonary Disease (COPD) Flare-Up Requiring Hospitalization Recruiting
A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007) Recruiting
Effectiveness of the WearME System for COPD Severity and Respiratory Function Recruiting
A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07430605 on ClinicalTrials.gov ↗ ← All trials in the USA