Early Detection of COPD Exacerbations Using Home Monitoring Device
Recruiting · NCT07554352 · Observational (researchers observe without assigning treatment) · Lead sponsor: RespirAI US Inc
View the official record on ClinicalTrials.gov →Interventions studied
RespirAI
What this trial is about
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.
Who can take part
Age range
21 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed across 1 US state.
- Methodist Physicians Clinic - Omaha, Nebraska, United States