Early Detection of COPD Exacerbations Using Home Monitoring Device

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.

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.