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

February 17, 2026 updated by: LASARRUS Clinic and Research Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins
        • Contact:
          • Edward S Chen, MD
          • Phone Number: (410) 550-5864
          • Email: echen3@jh.edu
        • Contact:
        • Sub-Investigator:
          • Adrian S Dobs, MD
      • Baltimore, Maryland, United States, 21230
      • Salisbury, Maryland, United States, 21801

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: WearME-Pro Patch System + Guided Training
Participants with COPD use the WearME-Pro patch system at home and complete scheduled sessions plus daily handheld spirometry. Participants receive guided onboarding/training on device setup, app workflow, and patch placement. Usability, adherence, and agreement between WearME-Pro predicted lung function and reference spirometry are evaluated. WearME-Pro outputs are investigational and not used for clinical decision-making.
Device: 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.
Device: 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).
Device: 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.
Experimental: WearME-Pro Patch System (Self-Guided / No Training)
Participants with COPD use the WearME-Pro patch system at home and complete scheduled sessions plus daily handheld spirometry. Participants follow self-guided instructions without guided training. Usability, adherence, and agreement between WearME-Pro predicted lung function and reference spirometry are evaluated. WearME-Pro outputs are investigational and not used for clinical decision-making.
Device: 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.
Device: 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).
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 10 months (daily paired measures through Month 10)
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.
Up to 10 months (daily paired measures through Month 10)
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.
Up to 10 months (daily paired measures through Month 10)
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.
End of Part A (Week 4; up to 1 month)
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.
Months 1-9

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Part A (Baseline/Onboarding through Week 4; up to 1 month)
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).
Part A (Baseline/Onboarding through Week 4; up to 1 month)
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.
Part A (Baseline/Onboarding through Week 4; up to 1 month)
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.
Up to 48 hours at Baseline and up to 48 hours at End of Study (Month 10)
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.
Up to 10 months (during daily sessions through Month 10)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LASARRUS Clinic and Research Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
TidalHealth

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Edward Chen, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 28, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 28, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LAS-02/03-WZ-024
  • 4R44HL172444 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings