Checks a wearable device for monitoring lung disease in COPD patients
Compares a wearable monitor with standard breathing tests in 128 adults with COPD.
Plain-language title generated from the registry record
Registry title: Effectiveness of the WearME System for COPD Severity and Respiratory Function
Key facts
- Where
- Baltimore and Salisbury, United StatesSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 21 and 100 years old?
Source: NCT06751537, who can take part
Where in United States
- Johns HopkinsBaltimore, United StatesTaking people
- TidalHealthSalisbury, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- LASARRUS Clinic and Research Center
- Trial code
- NCT06751537
- Record updated
- 9 September 2025
- Original 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.Read full original descriptionShow less
Effectiveness of WearME System for FEV1/FVC, Respiration and Activity Biomarkers in COPD Patients
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.
Inclusion: 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: Currently receiving invasive mechanical ventilation; Participants with known skin allergies or conditions that may interfere with device application or signal transmission.