RespirAI: Use of a software-based monitoring device for 6 months.
Study 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
Sex
ALL
Min age
21 Years
Max age
—
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.
Primary outcome measure(s)
Sensitivity — 6 months Percentage of clinically verified moderate or severe COPD exacerbation events detected by the device
False alam rate — 6 months The rate of false alarms produced by the device.
Trial sites (1)
Facility
City
Region
Status
Methodist Physicians Clinic
Omaha
Nebraska
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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