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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

Ages 21 and older · All sexes

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.

About the study

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.

What is being tested

• RespirAI (device)

Sponsor: RespirAI US Inc · Participants: 30 · Started: Aug 5, 2026

Contact the study team

• Tamar Sobol · Phone: (617) 615-6799‬

Official record on ClinicalTrials.gov — NCT07554352

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.