NCT06810323Recruiting
The ROAM Research Study Therapy (LTOT) Version
The Respiratory Oxygen Adherence Monitor System for COPD With Long Term Oxygen Therapy
Source: ClinicalTrials.gov · Last updated 5 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 15 Nov 2024
- Start date
- 14 Jan 2025
- Primary completion date
- Dec 2028
- Lead sponsor
- University of Virginia
- Diseases
- COPD
- NCT number
- NCT06810323
What you commit to
- Study type: Observational
- Planned participants: 100
- From 14 Jan 2025 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- No respiratory infections and exacerbation within 6 weeks of study
Other
- Post -Bronchodilator FEV1 \< 25%
- Intermittent oxygen use at home
- Inability to understand simple instructions
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.