The ROAM Research Study Therapy (LTOT) Version
Recruiting · NCT06810323 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Virginia
View the official record on ClinicalTrials.gov →What this trial is about
The purpose of this research is to test a device being developed that can see how patients use oxygen therapy over a long period of time. This study will focus on developing a new display part called ROAM module which will be attached to your oxygen source. The display will provide easily-accessible information that can show how you interact with your supplies and the oxygen machine automatically without connecting the oxygen source to the internet or other devices.
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Post-Bronchodilator FEV1/FVC \<.80
- Race demographics of the recruitment area reflect the population of the Charlottesville Metropolitan Statistical Area (MSA).
- Due to underrepresentation in local demographics, special effort (via targeted advertising) will be made to recruit Hispanic participants to better match national percentages.
- Participants with medical history of COPD
- Subjects has to have a 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 criteria
- Post -Bronchodilator FEV1 \< 25%
- Intermittent oxygen use at home
- Inability to understand simple instructions
- No respiratory infections and exacerbation within 6 weeks of study
Where it is running
1 location listed across 1 US state.
- University of Virginia - Charlottesville, Virginia, United States