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Effectiveness of the WearME System for COPD Severity and Respiratory Function

Description

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)
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Related Conditions:

Chronic Obstructive Pulmonary Disease (COPD)

Study Overview

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Study Details

Study overview

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.

Effectiveness of WearME System for FEV1/FVC, Respiration and Activity Biomarkers in COPD Patients

Effectiveness of the WearME System for COPD Severity and Respiratory Function

Condition
Chronic Obstructive Pulmonary Disease (COPD)
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins, Baltimore, Maryland, United States, 21224

Salisbury

TidalHealth, 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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.
  • * Participants with known skin allergies or conditions that may interfere with device application or signal transmission.
  • * Currently receiving invasive mechanical ventilation.

Ages Eligible for Study

21 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

LASARRUS Clinic and Research Center,

Study Record Dates

2026-02-28