NCT07554352Recruiting
Early Detection of COPD Exacerbations Using Home Monitoring Device
RespirAI US Inc
Start Date
8/5/2026
Completion Date
5/1/2027
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
Age Range: 21 years to No maximum
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.
Interventions
DEVICE
RespirAI
Conditions
COPD Exacerbation
Locations
Methodist Physicians Clinic
Omaha, Nebraska 68114
United States