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NCT Number: NCT07430605

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WearME-Pro Patch System

Device

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)

Device

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)

Device

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.

Primary outcomes

  1. Mean difference in FEV1 (L) between WearME-Pro predicted lung function and handheld spirometer

    Time frame: 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.

  2. Mean difference in FVC (L) between WearME-Pro predicted lung function and handheld spirometer

    Time frame: 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.

  3. Mean difference in FEV1/FVC (unitless ratio) between WearME-Pro predicted lung function and handheld spirometry

    Time frame: 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.

  4. System Usability Scale (SUS) total score (0-100)

    Time frame: 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.

  5. Monthly adherence rate to planned daily WearME-Pro sessions (%)

    Time frame: 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.

Secondary outcomes

  1. Single Ease Question (SEQ) score (7-point Likert scale)

    Time frame: Part A (Baseline/Onboarding through Week 4; up to 1 month)

    SEQ ratings collected during Part A to assess perceived ease of use for critical tasks (higher score indicates easier).

  2. Critical task success rate during Part A (%)

    Time frame: Part A (Baseline/Onboarding through Week 4; up to 1 month)

    Proportion of participants who successfully complete predefined critical tasks during Part A (reported as percent successful).

  3. Number of use errors during critical tasks in Part A

    Time frame: Part A (Baseline/Onboarding through Week 4; up to 1 month)

    Count of observed use errors during predefined critical tasks performed in Part A.

  4. Mean difference in heart rate (bpm) between WearME-Pro and Cardea SOLO ECG patch

    Time frame: Up to 48 hours at Baseline and up to 48 hours at End of Study (Month 10)

    Heart rate agreement will be summarized as the mean difference (WearME-Pro - Cardea SOLO) in beats per minute (bpm) during the monitoring windows in the optional subset.

  5. Respiratory rate (breaths per minute) measured by WearME-Pro

    Time frame: Up to 10 months (during daily sessions through Month 10)

    Respiratory rate measured by WearME-Pro during daily home-use sessions; summarized as the mean respiratory rate (breaths/min) during each session, and averaged across sessions through Month 10.

Study contacts

Contact information is provided by the study sponsor or research team.

Lloyd E Emokpae, PhD.

CONTACT

[email protected]

301-388-5453

Roland N Emokpae, Jr., MD

CONTACT

[email protected]

301-388-8067

Sponsors and collaborators

Lead sponsor

LASARRUS Clinic and Research Center

Industry

Collaborators

  • Johns Hopkins University
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)
  • Tidalhealth

Registry information

Official study title

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

Acronym: WearME-Pro

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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