COPD Exacerbation
Conditions
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.
Interventions
DEVICERespirAI
Use of a software-based monitoring device for 6 months.
Sponsors
RespirAI US Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTTamar Sobol
PRINCIPAL_INVESTIGATORAdam D Wells, MD, FCCP
Nebraska Methodist Hospital
Outcome results
None listed