Early Detection of COPD Exacerbations Using Home Monitoring Device

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
RespirAI US Inc
Study ID
NCT07554352
Status
Not Yet Recruiting

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Conditions

  • COPD Exacerbation

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RespirAI — DEVICE
    Use of a software-based monitoring device for 6 months.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Sensitivity [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Methodist Physicians ClinicOmahaNebraska68114
DruAnne H McMartin, CCRC, MA
402-354-0350
Rebecca A Van Winkle, RN, BSN
(402) 354-0350
Adam D Wells, MD, FCCP (PRINCIPAL_INVESTIGATOR)
Michael J Sanley, MD (SUB_INVESTIGATOR)
Zachariah L Wittenberg, DO (SUB_INVESTIGATOR)

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