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Recruiting Observational

Effectiveness of the WearME System for COPD Severity and Respiratory Function

NCT06751537 · tracked via the Priya Life Science USA tracker
Sponsor
LASARRUS Clinic and Research Center
Phase
Observational
Started
2025-05-29
Last updated
2025-09-09

Condition(s) studied

Chronic Obstructive Pulmonary Disease (COPD)

Study summary

This observational study evaluates the effectiveness of the WearME system in monitoring COPD severity and respiratory function by comparing its measurements to standard spirometry, capnography, and other clinical assessments in 128 COPD participants.

Eligibility

Sex
ALL
Min age
21 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: * Adult participants aged 21-100 years, of any sex, and of any race/ethnicity, who are able to understand and sign consent documents in English or Spanish. * Diagnosed with COPD as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria \[5\] , with the following severity levels (confirmed via spirometry performed after consent): * Mild: FEV1/FVC \< 0.7 and FEV1 ≥ 80% * Moderate: FEV1/FVC \< 0.7 and 50% ≤ FEV1 \< 80% * Severe: FEV1/FVC \< 0.7 and 30% ≤ FEV1 \< 50% * Very Severe: FEV1/FVC \< 0.7 and FEV1 \< 30% or FEV1 \< 50%, plus chronic respiratory failure. Note: Participants will be consented and enrolled based on prior diagnosis of COPD from medical records within the past year to confirm eligibility and stratify COPD severity levels. Spirometry will be performed during concurrent data collection with the WearME device for comparison. Screening failures are expected and will be recorded and managed appropriately. * Current, former, or never smoker; any amount of time between quitting and study enrollment is allowed). * Ability to understand and willingness to sign consent documents. * Able to participate in study procedures as required. Exclusion Criteria: * Participants with known skin allergies or conditions that may interfere with device application or signal transmission. * Currently receiving invasive mechanical ventilation.

Primary outcome measure(s)

  • Agreement between WearME-Pro system and gold standard devices for FEV1 measurements, stratified by COPD severity. — Within 6 months of study start.
    The primary outcome measure will be the Bland-Altman LOA between the FEV1/FVC measurements of WearME-Pro FEV1/FVC prediction (recorded within the WearME-Basic app but not displayed to users) and the gold standard devices.

Trial sites (2)

FacilityCityRegionStatus
Johns Hopkins Baltimore Maryland Recruiting
TidalHealth Salisbury Maryland Recruiting

More LASARRUS Clinic and Research Center trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06751537 on ClinicalTrials.gov ↗ ← All trials in the USA