Device Tracking Oxygen Use in People with COPD
Tests a device that gives oxygen-use feedback to adults with COPD on long-term oxygen.
Plain-language title generated from the registry record
Registry title: Respiratory Oxygen Adherence Monitor for Chronic Obstructive Pulmonary Disease Patients
Key facts
- Where
- Charlottesville, United StatesSee the site
Where in United States
- University of VirginiaCharlottesville, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Barron Associates, Inc.
- Trial code
- NCT06874101
- Record updated
- 13 March 2025
- Original description
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?Read full original descriptionShow less
Evaluating a Respiratory Oxygen Adherence Monitor for COPD Patients With Long-term Oxygen Therapy
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.
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: Respiratory exacerbation or infections within 6 weeks prior to screen visit; Not at baseline of medical health prior to screen visit; Post -Bronchodilator FEV1/FVC ≤25%; Intermittent oxygen use at home; Inability to understand simple instructions.