Chronic Obstructive Pulmonary Disease (COPD)WearME-ProNCT07430605
WearME-Pro Phase II: Remote Use Usability and Longitudinal Validation Study (Patch Form Factor).
A study testing WearME-Pro Patch System, FDA-cleared handheld spirometer (reference comparator) and Cardea SOLO ECG patch (optional subset; exploratory HR reference) in people with Chronic Obstructive Pulmonary Disease (COPD), run by LASARRUS Clinic and Research Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- WearME-Pro Patch System, FDA-cleared handheld spirometer (reference comparator) and Cardea SOLO ECG patch (optional subset; exploratory HR reference)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 May 2026to 28 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Johns Hopkins
Baltimore, Maryland, 21224
Edward S Chen, MD, (410) 550-5864, echen3@jh.edu
Tianzhi Mao, (410)502-5819, tmao2@jhmi.edu
LASARRUS Clinic and Research Center Inc.
Baltimore, Maryland, 21230
Lloyd Emokpae, PhD, 301-388-5453, lloyd.emokpae@lasarrus.com
Roland N Emokpae, Jr., MD, 301-388-8067, roland.emokpae.jr@lasarrus.com
TidalHealth
Salisbury, Maryland, 21801
Robert T Chasse, MD, 410-543-7722, Robert.Chasse@tidalhealth.org
Robert Joyner, PhD., RRT, 410-543-7017, Robert.Joyner@tidalhealth.org
About this study
Official title: 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.
Read the 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.
- Being tested
- WearME-Pro Patch System, FDA-cleared handheld spirometer (reference comparator), Cardea SOLO ECG patch (optional subset; exploratory HR reference)
- Keywords
- COPD, Wearable sensor, WearME, Remote monitoring, Home use, Lung function, Spirometry, FEV1, FVC, FEV1/FVC, Usability, Human factors, Adherence, Mobile application, Patch
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WearME-Pro Patch SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| WearME-Pro Patch System + Guided Training | Experimental | 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. Receives: Device: WearME-Pro Patch System; Device: FDA-cleared handheld spirometer (reference comparator); Device: Cardea SOLO ECG patch (optional subset; exploratory HR reference) |
| WearME-Pro Patch System (Self-Guided / No Training) | Experimental | 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. Receives: Device: WearME-Pro Patch System; Device: FDA-cleared handheld spirometer (reference comparator); Device: Cardea SOLO ECG patch (optional subset; exploratory HR reference) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference in FEV1 (L) between WearME-Pro predicted lung function and handheld spirometer
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.
Measured: Up to 10 months (daily paired measures through Month 10)
Mean difference in FVC (L) between WearME-Pro predicted lung function and handheld spirometer
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.
Measured: 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
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.
Measured: Up to 10 months (daily paired measures through Month 10)
System Usability Scale (SUS) total score (0-100)
SUS questionnaire to assess usability for intended users in Part A (human factors/usability). Target mean SUS > 85 over the usability period.
Measured: End of Part A (Week 4; up to 1 month)
Monthly adherence rate to planned daily WearME-Pro sessions (%)
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.
Measured: Months 1-9
Secondary outcomes (5)
Single Ease Question (SEQ) score (7-point Likert scale)
SEQ ratings collected during Part A to assess perceived ease of use for critical tasks (higher score indicates easier).
Measured: Part A (Baseline/Onboarding through Week 4; up to 1 month)
Critical task success rate during Part A (%)
Proportion of participants who successfully complete predefined critical tasks during Part A (reported as percent successful).
Measured: Part A (Baseline/Onboarding through Week 4; up to 1 month)
Number of use errors during critical tasks in Part A
Count of observed use errors during predefined critical tasks performed in Part A.
Measured: 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
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.
Measured: 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
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.
Measured: Up to 10 months (during daily sessions through Month 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 May 2026 (estimated)
- Primary completion28 Apr 2028 (estimated)
- Study completion28 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two-component protocol. Part A is a parallel-assignment summative usability study in people with COPD: Training (guided onboarding) vs No-training (self-guided) for \~1 month. Part B is a 10-month longitudinal home-use clinical performance component comparing WearME-Pro predicted lung function to daily handheld spirometry. Participants may enroll in Part A, Part B, or both (Part A first if both).
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LASARRUS Clinic and Research Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University, Tidalhealth, National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Edward Chen, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430605
- Sponsor's protocol ID
- LAS-02/03-WZ-024
- Other IDs
- 4R44HL172444
- Acronym
- WearME-Pro
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WearME-Pro Phase II: Remote Use Usability and Longitudinal Validation Study (Patch Form Factor)
- ClinicalTrials.gov ID
- NCT07430605
- Acronym / sponsor ID
- WearME-Pro / LAS-02/03-WZ-024
- Keywords
- COPD, Wearable sensor, WearME, Remote monitoring, Home use, Lung function, Spirometry, FEV1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- LASARRUS Clinic and Research CenterIndustry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University, Tidalhealth, National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 28 Apr 2028 (estimated)
- Study completion
- 28 Apr 2028 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-component protocol. Part A is a parallel-assignment summative usability study in people with COPD: Training (guided onboarding) vs No-training (self-guided) for ~1 month. Part B is a 10-month longitudinal home-use clinical performance component comparing WearME-Pro predicted lung function to daily handheld spirometry. Participants may enroll in Part A, Part B, or both (Part A first if both).
| Arm | Type | Receives |
|---|---|---|
| WearME-Pro Patch System + Guided Training | Experimental | Device: WearME-Pro Patch System, Device: FDA-cleared handheld spirometer (reference comparator), Device: Cardea SOLO ECG patch (optional subset; exploratory HR reference)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. |
| WearME-Pro Patch System (Self-Guided / No Training) | Experimental | Device: WearME-Pro Patch System, Device: FDA-cleared handheld spirometer (reference comparator), Device: Cardea SOLO ECG patch (optional subset; exploratory HR reference)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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WearME-Pro Patch SystemWearable 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 | WearME-Pro Patch System (Self-Guided / No Training), WearME-Pro Patch System + Guided Training |
| 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 | WearME-Pro Patch System (Self-Guided / No Training), WearME-Pro Patch System + Guided Training |
| 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. | Device | WearME-Pro Patch System (Self-Guided / No Training), WearME-Pro Patch System + Guided Training |
Primary outcome
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.
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.
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.
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.
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.
5 secondary outcomes
Single Ease Question (SEQ) score (7-point Likert scale)
Time frame: 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)
Number of use errors during critical tasks in Part A
Time frame: 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)
Respiratory rate (breaths per minute) measured by WearME-Pro
Time frame: Up to 10 months (during daily sessions through Month 10)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edward Chen, MD principal investigator
Johns Hopkins University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WearME-Pro Patch System, FDA-cleared handheld spirometer (reference comparator) and Cardea SOLO ECG patch (optional subset; exploratory HR reference) in people with Chronic Obstructive Pulmonary Disease (COPD), run by LASARRUS Clinic and Research Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lloyd E Emokpae, PhD. (301-388-5453, lloyd.emokpae@lasarrus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.