Early Detection of COPD Exacerbations Using Home Monitoring Device
ConditionCOPD Exacerbation
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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 population
Adults aged 21 and older with physician-diagnosed COPD who are at high risk for exacerbations.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
RespirAI
DeviceUse of a software-based monitoring device for 6 months.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: High risk COPD patients1 intervention
Trial outcomes
Primary outcomes
1
Sensitivity
Percentage of clinically verified moderate or severe COPD exacerbation events detected by the device
Time frame
6 months2
False alam rate
The rate of false alarms produced by the device.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov