Early Detection of COPD Exacerbations Using Home Monitoring Device
Part of paid clinical trials in Omaha, Nebraska.
- Sponsor
- RespirAI US Inc
- Study ID
- NCT07554352
- Status
- Not Yet Recruiting
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Conditions
- COPD Exacerbation
Eligibility Criteria
- Sex
- ALL
- Age
- 21 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- RespirAI — DEVICEUse of a software-based monitoring device for 6 months.
Study Details
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.
Key Dates
- Start date
- May 31, 2026
- Status verified
- Apr 2026
- Primary completion
- May 31, 2027
- Completion
- May 31, 2027
Study Design
- Enrollment
- 30 participants (estimated)
Arms
- Arm: High risk COPD patientsAdults aged 21 years and older with physician-diagnosed COPD who are at high risk for exacerbations, wearing a study device for 6 months.
Primary Outcome Measure
Sensitivity [ Time Frame: 6 months ]
Central Contacts
- Tamar Sobol(617) 615-6799
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Methodist Physicians Clinic | Omaha | Nebraska | 68114 | Adam D Wells, MD, FCCP (PRINCIPAL_INVESTIGATOR) Michael J Sanley, MD (SUB_INVESTIGATOR) Zachariah L Wittenberg, DO (SUB_INVESTIGATOR) |
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