Clinical trial Recruiting at 1 site Observational

Monitoring oxygen therapy usage in COPD patients

Official title: The Respiratory Oxygen Adherence Monitor System for COPD With Long Term Oxygen Therapy

Run by University of Virginia · NCT06810323 · Data updated 2026-11-12

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 typeObservational
SexAll
Enrollment100 (estimated)
SponsorUniversity of Virginia
Academic / other
Locations1 site (Charlottesville, Virginia)
StatusRecruiting
StartedJanuary 14, 2025
Main results expectedDecember 2028
Study endsDecember 2030
Registry record updatedFebruary 5, 2025
Trial IDNCT06810323 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients who use intermittent oxygen or have severe respiratory conditions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Other studies have shown promise in using technology to monitor adherence to therapy, suggesting that this approach could be effective.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.