Effectiveness of the WearME System for COPD Severity and Respiratory Function
Effectiveness of WearME System for FEV1/FVC, Respiration and Activity Biomarkers in COPD Patients
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 21 Years to 100 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
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.
Study sites (2)
MD
- Johns Hopkins · Baltimore, MD 21224Chathurangi Pathiravasan, PhD · Study contact · 617-416-6222 · cpathir1@jh.eduAdrian S Dobs, MD · Study contact · 443-604-3745 · adobs@jhmi.eduEdward Chen, MD · Sub-investigatorMore trials in Baltimore
- TidalHealth · Salisbury, MD 21801Robert L Joyner, PhD · Study contact · 410-543-7017 · Robert.Joyner@tidalhealth.orgSandra Fetko, MSN · Study contact · 410-912-6045 · Sandra.Fetko@tidalhealth.orgRobert T Chasse, MD · Principal investigatorMore trials in Salisbury