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.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- RespirAI US Inc
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Sensitivity
Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
High risk COPD patients
Adults aged 21 years and older with physician-diagnosed COPD who are at high risk for exacerbations, wearing a study device for 6 months.
Intervention: RespirAI (Device)
Outcomes
Primary Outcomes
Sensitivity
Time Frame: 6 months
Percentage of clinically verified moderate or severe COPD exacerbation events detected by the device
False alam rate
Time Frame: 6 months
The rate of false alarms produced by the device.
Secondary Outcomes
No secondary outcomes reported