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NCT Number: NCT07554352

Early Detection of COPD Exacerbations Using Home Monitoring Device

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.

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Key information

Conditions

COPD Exacerbation

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Methodist Physicians Clinic

Omaha, Nebraska, 68114, United States

Location contact

Adam D Wells, MD, FCCP

PRINCIPAL_INVESTIGATOR

DruAnne H McMartin, CCRC, MA

CONTACT

[email protected]

402-354-0350

Michael J Sanley, MD

SUB_INVESTIGATOR

Rebecca A Van Winkle, RN, BSN

CONTACT

[email protected]

(402) 354-0350

Zachariah L Wittenberg, DO

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RespirAI

Device

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

Primary outcomes

  1. Sensitivity

    Time frame: 6 months

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

  2. False alam rate

    Time frame: 6 months

    The rate of false alarms produced by the device.

Study contacts

Contact information is provided by the study sponsor or research team.

Tamar Sobol

CONTACT

[email protected]

(617) 615-6799‬

Sponsors and collaborators

Lead sponsor

RespirAI US Inc

Industry

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 28, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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