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

NCT07430605 | Not Yet Recruiting FDA Device

• 2 other identifiers: LAS-02/03-WZ-0244R44HL172444
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; Wearable sensor; WearME; Remote monitoring; Home use; Lung function; Spirometry; FEV1; FVC; FEV1/FVC; Usability; Human factors; Adherence; Mobile application; Patch

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Months 1-9

Secondary Outcomes (5)

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

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

• Critical task success rate during Part A (%)

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

• Number of use errors during critical tasks 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

  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

  Up to 10 months (during daily sessions through Month 10)

Study Arms (2)

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.

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.

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

Interventions

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.

WearME-Pro Patch System (Self-Guided / No Training); WearME-Pro Patch System + Guided Training

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).

WearME-Pro Patch System (Self-Guided / No Training); WearME-Pro Patch System + Guided Training

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.

WearME-Pro Patch System (Self-Guided / No Training); WearME-Pro Patch System + Guided Training

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LASARRUS Clinic and Research Center: lead
• Johns Hopkins University: collaborator
• Tidalhealth: collaborator
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (3)

Johns Hopkins

Baltimore, Maryland, 21224, United States

Location

LASARRUS Clinic and Research Center Inc.

Baltimore, Maryland, 21230, United States

Location

TidalHealth

Salisbury, Maryland, 21801, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Edward Chen, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lloyd E Emokpae, PhD.

CONTACT

301-388-5453; lloyd.emokpae@lasarrus.com

Roland N Emokpae, Jr., MD

CONTACT

301-388-8067; roland.emokpae.jr@lasarrus.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 24, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 28, 2028
• Study Completion (Estimated): April 28, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

US (3)