No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
21 – 100
Sex
Any
Study type
Observational
Participants needed
128 (estimated)
Sponsor
LASARRUS Clinic and Research Center · Industry
Who this trial is looking for
This trial is looking for adults with Chronic Obstructive Pulmonary Disease (COPD) to see how well the WearME system can monitor their condition. Participants will have tests done while using the WearME device to compare its results with standard methods.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 21 and 100 years old.
I have been diagnosed with COPD.
I can understand and sign consent documents in English or Spanish.
I smoke, used to smoke, or have never smoked.
I can participate in study procedures.
You may not be able to join if
I have known skin allergies that affect device use.
I am currently receiving invasive mechanical ventilation.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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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 fo…
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.
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