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Early Detection of COPD Exacerbations Using Home Monitoring Device

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.

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study checks how safely and accurately the RespirAI home device can spot early signs of COPD flare-ups. COPD is a long-term lung disease that makes breathing hard. The study is for adults over 21 with COPD who have a high risk of flare-ups, and it compares AI predictions with flare-ups recorded by health care providers.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are older than 21.
  • A doctor diagnosed you with COPD at least 6 months before the screening visit.
  • You had at least 2 moderate COPD flare-ups or 1 severe flare-up in the past 6 months.
  • You had no COPD flare-ups in the month before joining.

Who can't join

  • You cannot or will not sign the consent form to agree to join the study.
  • A physical or mental health condition keeps you from completing a 6-minute walk test.
  • You have a pacemaker, defibrillator, or another electronic device placed inside your body.
  • You are pregnant.
  • The study clinician decides you cannot or will not follow all study steps.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

NE