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

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Not accepted

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.
• 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 Details

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.

Key Dates

Start date

May 1, 2026

Status verified

Feb 2026

Primary completion

Apr 28, 2028

Completion

Apr 28, 2028

Study Design

Enrollment

82 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• 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.
• 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.

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) ]

Central Contacts

• Lloyd E Emokpae, PhD.
  301-388-5453
  [email protected]
• Roland N Emokpae, Jr., MD
  301-388-8067
  [email protected]

Locations (3)

Find similar trials in Baltimore, MD

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