Early Detection of COPD Exacerbations Using Home Monitoring Device
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RespirAI.
- Who it may be relevant to
- Registry conditions: COPD Exacerbation. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multi-center, Observational Prospective Clinical Study to Evaluate the Safety and Effectiveness of a Home - Monitoring COPD Management Software for Early Detection of Exacerbations.
Overview
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]
- False alam rate [Time frame: 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Methodist Physicians Clinic — Omaha
Identifiers
NCT: NCT07554352 · CL-020