Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07430605
Eligibility Criteria:
Inclusion Criteria:
* Age 21 years or older, either sex.
* Diagnosed with COPD per GOLD criteria (GOLD 2025): post-bronchodilator FEV1/FVC \< 0.70; stratified by post-bronchodilator FEV1% predicted (severity strata).
* On stable maintenance therapy for at least 2 months (no COPD medication class changes or dose escalations).
* Current, former, or never smoker (smoking history collected but not an eligibility requirement).
* Able to perform activities of daily living and complete study procedures (e.g., sit upright and perform spirometry maneuvers).
* Able and willing to provide informed consent.
* Not currently enrolled in another investigational device study that could confound outcomes (prior WearME-Basic Phase I participation permitted if completed and not concurrent).
* Owns a compatible smartphone/tablet or willing to use a loaner device.
* Willing to wear WearME-Pro patch and perform daily handheld spirometry throughout the study.
* Optional subset only: willing to wear Cardea SOLO ECG patch for up to 24-48 hours at baseline and end of study if selected.
Exclusion Criteria:
* COPD exacerbation within past 6 weeks requiring systemic corticosteroids and/or antibiotics, urgent/ED visit, or hospitalization.
* Known allergy or severe skin sensitivity to medical adhesives, or dermatologic conditions at intended placement sites.
* Any condition that, in the investigator's opinion, may interfere with compliance or safety.
* Inability or unwillingness to perform daily spirometry or to use the mobile app.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT07430605
Study Brief:
Protocol Section:
NCT07430605