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NCT07554352
Early Detection of COPD Exacerbations Using Home Monitoring Device
Conditions: COPD Exacerbation
Sex: All
Ages: 21 Years – N/A
Healthy volunteers: No
Enrollment: 30
Sponsor: RespirAI US Inc
Location: Methodist Physicians Clinic Omaha Nebraska
Summary
The goal of this observational study is to evaluate the safety and effectiveness of a home-monitoring device (RespirAI) in the early detection of COPD exacerbations in adults (age \>21) with physician-diagnosed COPD who are at high risk for exacerbations. The study will collect data from participants with COPD that will be analyzed using an AI-based algorithm to predict exacerbation events. The device's predictions will then be compared against clinically documented exacerbations to assess detection accuracy.
Eligibility Criteria
Inclusion Criteria:
* Age \>21 years.
* Physician-diagnosed COPD at least 6 months prior to screening visit.
* Two or more moderate COPD exacerbations in the past 6 months or 1 severe exacerbation during the past 6 months.
* Free of exacerbation for 1 month before enrollment.
Exclusion Criteria:
* Unable or willing to sign an informed consent.
* Unable to complete the 6-minute walk test due to physical or mental health conditions.
* Patients with cardiac pacemaker, defibrillators, or other implanted electronic devices.
* Pregnancy
* Study clinician determines that the patient is unable or unwilling to comply with all study procedures.
Source: ClinicalTrials.gov (NCT07554352). StuddyBuddy aggregates publicly available trial information.