NCT06751537 Effectiveness of the WearME System for COPD Severity and Respiratory Function
| NCT ID | NCT06751537 |
| Status | Recruiting |
| Phase | — |
| Sponsor | LASARRUS Clinic and Research Center |
| Condition | Chronic Obstructive Pulmonary Disease (COPD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 128 participants |
| Start Date | 2025-05-29 |
| Primary Completion | 2026-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 128 participants in total. It began in 2025-05-29 with a primary completion date of 2026-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06751537 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 100 Years, studying Chronic Obstructive Pulmonary Disease (COPD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06751537 currently recruiting?
Yes, NCT06751537 is actively recruiting participants. Contact the research team at lloyd.emokpae@lasarrus.com for enrollment information.
Where is the NCT06751537 trial being conducted?
This trial is being conducted at Baltimore, United States, Salisbury, United States.
Who is sponsoring the NCT06751537 clinical trial?
NCT06751537 is sponsored by LASARRUS Clinic and Research Center. The trial plans to enroll 128 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.