Status:
NOT_YET_RECRUITING
Respiratory Oxygen Adherence Monitor for Chronic Obstructive Pulmonary Disease Patients
Lead Sponsor:
Barron Associates, Inc.
Collaborating Sponsors:
University of Virginia
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
COPD
COPD - Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to test a device called "ROAM" that is being developed to see how patients with chronic obstructive pulmonary disease (COPD) use oxygen therapy over a long period of...
Detailed Description
This clinical trial will be a conventional randomized, parallel controlled trial to evaluate the primary hypothesis that a 4-week period of using the ROAM adherence monitor and support system will res...
Eligibility Criteria
Inclusion
- Post-Bronchodilator FEV1/FVC\<.80
- Participants with medical history of COPD
- Prescription for oxygen use via nasal cannula or mask at home
- At baseline of health with no hospitalization/exacerbation within the past 6 weeks
- Use of Continuous oxygen at baseline
Exclusion
- Post -Bronchodilator FEV1/FVC ≤25%
- Intermittent oxygen use at home
- Inability to understand simple instructions
- Respiratory exacerbation or infections within 6 weeks prior to screen visit
- Not at baseline of medical health prior to screen visit
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06874101
Start Date
May 1 2025
End Date
April 30 2026
Last Update
March 13 2025
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22903