Early Detection of COPD Exacerbations Using Home Monitoring Device

RespirAI US Inc

Status: Not yet enrolling

Conditions: COPD Exacerbation

Treatments: Device: RespirAI

Study type: Observational

Funder types: Industry

Identifiers

NCT07554352

CL-020

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

High risk COPD patients

Description:

Adults aged 21 years and older with physician-diagnosed COPD who are at high risk for exacerbations, wearing a study device for 6 months.

Treatment:

Device: RespirAI