Clinical Trial

Respiratory Oxygen Adherence Monitor for Chronic Obstructive Pulmonary Disease Patients

Study acronym: ROAM
Not Yet Recruiting
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Record status
This record was last updated March 13, 2025 (before its estimated April 1, 2026 completion). Its status may not reflect the trial's current state.
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 time. This study will focus on evaluating the ROAM device, which will be attached to your oxygen source. The question that the study aims to answer is: will patients who receive daily adherence feedback from the ROAM have increased adherence to their prescribed long term oxygen therapy regimens? Researchers will compare the amount of time using oxygen and attitudes about oxygen therapy observed in a group that receives feedback from ROAM, and a control group that does not receive feedback. Participants will have their oxygen supplies fitted with the ROAM device and then use their oxygen as usual for the 5-week study duration. Participants in the study group will have access to information about their oxygen usage and pulse oximetry levels. All participants will attend two in-clinic sessions of about an hour each, and will complete questionnaires at the beginning and end of the study.
Trial Details
NCT Number NCT06874101
Lead Sponsor Barron Associates, Inc.
Collaborators: University of Virginia, National Heart, Lung, and Blood Institute (NHLBI)
Conditions COPD, COPD - Chronic Obstructive Pulmonary Disease
Enrollment 100 participants
Start Date 2025-05-01
Primary Completion 2026-04-01 (estimated)
Study Completion 2026-04-30 (estimated)
Updated on ClinicalTrials.gov 2025-03-13