Effectiveness of the WearME System for COPD Severity and Respiratory Function

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

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.

Conditions2

Locations2 sites

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