Recruiting

Observational Study

Sponsor:

RespirAI US Inc

Code:

NCT07554352

Conditions

COPD Exacerbation

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

RespirAI

Study Details

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

Study ID

NCT07554352

Start date

Aug 5, 2026

Status verified date

Apr, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

RespirAI

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

Primary outcome measure

  • Sensitivity [ Time Frame: 6 months ]
  • False alam rate [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Tamar Sobol

(617) 615-6799‬info@respriai.com

Locations

Methodist Physicians Clinic

Recruiting

Omaha, Nebraska, United States, 68114

Contacts

DruAnne H McMartin, CCRC, MA

402-354-0350dru.mcmartin@nmhs.org

Rebecca A Van Winkle, RN, BSN

(402) 354-0350rebecca.vanwinkle@nmhs.org

Principal Investigator:

Adam D Wells, MD, FCCP

More Information

Sponsor

RespirAI US Inc

Last update posted

Aug 10, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by RespirAI US Inc on 2026-08-10.