WearME system to monitor COPD severity and lung function

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational project will enroll about 128 adults with COPD at Johns Hopkins and TidalHealth sites to compare measurements from the WearME wearable with standard spirometry, capnography, and other clinical assessments. Participants will be stratified by COPD severity using GOLD criteria and will undergo concurrent spirometry while wearing the device to validate metrics such as respiratory rate, FEV1, FVC, and I:E ratio. The same hardware supports both Basic and Pro app functionality, allowing investigators to analyze multiple algorithms from a single data collection. The collaboration with NHLBI and the Johns Hopkins Clinical Research Network aims to include underserved, rural, and ethnically diverse patients in the Mid‑Atlantic to evaluate real-world performance.

Why it matters

Who can join: the full rules

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.

Where it's running

• Johns Hopkins
  Baltimore, Maryland, United States Recruiting
• TidalHealth
  Salisbury, Maryland, United States Recruiting

Study contacts

• Study coordinator: Lloyd E Emokpae, PhD.
• Email: lloyd.emokpae@lasarrus.com
• Phone: 301-388-5453

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.