Monitoring oxygen therapy usage in COPD patients
The Respiratory Oxygen Adherence Monitor System for COPD With Long Term Oxygen Therapy
University of Virginia · NCT06810323
This study is testing a new device that tracks how well COPD patients are using their oxygen therapy to help them breathe better and stay healthier.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | University of Virginia (other) |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT06810323 on ClinicalTrials.gov |
What this trial studies
This research focuses on the development of the Respiratory Oxygen Adherence Monitor (ROAM) system, which tracks how patients use oxygen therapy over time. The ROAM module attaches to the oxygen source and provides real-time feedback on usage patterns without needing internet connectivity. By objectively measuring adherence to long-term oxygen therapy (LTOT), the study aims to enhance clinical management for patients with chronic obstructive pulmonary disease (COPD) and improve health outcomes while reducing healthcare costs associated with non-adherence. The study will also target recruitment efforts to ensure diverse representation among participants.
Who should consider this trial
Good fit: Ideal candidates include patients with a medical history of COPD who have a prescription for continuous oxygen use and are stable without recent hospitalizations.
Not a fit: Patients who use intermittent oxygen or have severe respiratory conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve adherence to oxygen therapy in COPD patients, leading to better health outcomes and reduced healthcare costs.
How similar studies have performed: Other studies have shown promise in using technology to monitor adherence to therapy, suggesting that this approach could be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Charlottesville, Virginia
- University of Virginia — Charlottesville, Virginia, United States (RECRUITING)
Study contacts
- Principal investigator: Yun M Shim, MD — Division of Pulmonary and Critical Medicine
- Study coordinator: Roselove NUNOO-ASARE, MA
- Email: RNN3B@VIRGINIA.EDU
- Phone: 434-243-6074
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pulmonary Disease, Chronic Obstructive