A Multi-center, Observational Prospective Clinical Study to Evaluate the Safety and Effectiveness of a Home - Monitoring COPD Management Software for Early Detection of Exacerbations.
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.
• 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.