Early Detection of COPD Exacerbations Using Home Monitoring Device

April 21, 2026 updated by: RespirAI US Inc

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Methodist Physicians Clinic
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adam D Wells, MD, FCCP
        • Sub-Investigator:
          • Michael J Sanley, MD
        • Sub-Investigator:
          • Zachariah L Wittenberg, DO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Use of a software-based monitoring device for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: 6 months
Percentage of clinically verified moderate or severe COPD exacerbation events detected by the device
6 months
False alam rate
Time Frame: 6 months
The rate of false alarms produced by the device.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RespirAI US Inc

Investigators

  • Principal Investigator: Adam D Wells, MD, FCCP, Nebraska Methodist Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 21, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 28, 2026

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • CL-020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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