Early Detection of COPD Exacerbations Using Home Monitoring Device

NCT07554352 | Not Yet Recruiting FDA Device

• 1 other identifier: CL-020
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD Exacerbation

Outcome Measures

Primary Outcomes (2)

• Sensitivity

  Percentage of clinically verified moderate or severe COPD exacerbation events detected by the device

  6 months

• False alam rate

  The rate of false alarms produced by the device.

  6 months

Study Arms (1)

High risk COPD patients

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

Device: RespirAI

Interventions

RespirAI DEVICE

Use of a software-based monitoring device for 6 months.

High risk COPD patients

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults aged 21 and older with physician-diagnosed COPD who are at high risk for exacerbations.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RespirAI US Inc: lead

Study Sites (1)

Methodist Physicians Clinic

Omaha, Nebraska, 68114, United States

Location

Study Officials

• Adam D Wells, MD, FCCP

  Nebraska Methodist Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamar Sobol

CONTACT

(617) 615-6799‬; info@respriai.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)