Early Detection of COPD Exacerbations Using Home Monitoring Device
ConditionCOPD Exacerbation
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorRespirAI US Inc
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- RespirAI
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov