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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Wearing a device, Heart tracing (ECG), Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe, easy to use, and accurate the WearME-Pro patch system is for adults with COPD, a lung disease that makes breathing hard. It includes about 1 month of ease-of-use testing and a 10-month home study comparing the patch’s lung readings with a handheld breathing test device. The patch readings will not guide medical care during the study.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 21 or older and have COPD confirmed by a breathing test after taking medicine that opens the airways.
  • Have used steady COPD treatment for at least 2 months, with no changes in medicine type or dose increases.
  • Be able to do daily activities and study tasks, such as sitting upright and doing breathing tests.
  • Be able and willing to give informed consent, meaning you understand and agree to join.
  • Not be in another test-device study that could affect the results. Past WearME-Basic Phase I participation is allowed if finished.
  • Own a compatible smartphone or tablet, or be willing to use a loaned device.
  • Be willing to wear the patch and do daily handheld breathing tests throughout the study.
  • For an optional group only: be willing to wear a Cardea SOLO heart-recording patch for up to 24–48 hours at the start and end.

Who can't join

  • Had a COPD flare-up in the past 6 weeks that needed steroid medicine, antibiotics, urgent or emergency care, or a hospital stay.
  • Have an allergy or severe skin sensitivity to medical adhesives, or a skin condition where the patch would go.
  • Have a condition that the study doctor thinks could make participation unsafe or make study tasks hard to follow.
  • Cannot or will not do daily breathing tests or use the mobile app.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (3)

MD