NCT06810323 · University of Virginia
The ROAM Research Study Therapy (LTOT) Version
(ROAM)
What this study 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.
View original scientific description
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 participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Charlottesville, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 5, 2025 · Source of record for eligibility and locations