Early detection of COPD flares with a home monitoring device

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study tests the RespirAI home-monitoring device in adults over 21 with physician-diagnosed COPD who have recently had multiple exacerbations. An AI-based algorithm analyzes device data to predict impending exacerbations, and predictions are compared to clinically documented events to measure accuracy. The study will assess safety and effectiveness of the device’s monitoring approach in real-world use. Participants will provide data while continuing standard COPD care at participating sites. The study is led by RespirAI US Inc with collaboration at Methodist Physicians Clinic in Omaha, Nebraska.

Why it matters

Who can join: the full rules

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.

Where it's running

• Methodist Physicians Clinic
  Omaha, Nebraska, United States Recruiting

Study contacts

• Principal investigator: Adam D Wells, MD, FCCP — Nebraska Methodist Hospital
• Study coordinator: Tamar Sobol
• Email: info@respriai.com
• Phone: (617) 615-6799‬

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.