NCT07554352 · RespirAI US Inc
Early Detection of COPD Exacerbations Using Home Monitoring Device
What this study 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.
View original scientific description
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.
Interventions
DEVICE
RespirAI
Use of a software-based monitoring device for 6 months.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- Study clinician determines that the patient is unable or unwilling to comply with all study procedures.
Where
- Omaha, Nebraska
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 10, 2026 · Source of record for eligibility and locations