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Tests a device that tracks how people use long-term oxygen for COPD

Studies a new display device that records how COPD patients use home oxygen.

Plain-language title generated from the registry record
Registry title: The ROAM Research Study Therapy (LTOT) Version

Key facts

Where
Charlottesville, United StatesSee the site

Where in United States

  • University of VirginiaCharlottesville, United StatesTaking people

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Trial details

Who runs it
University of Virginia
Trial code
NCT06810323
Record updated
5 February 2025
Original 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.Read full original descriptionShow less

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

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.

Inclusion: 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: No respiratory infections and exacerbation within 6 weeks of study; Post -Bronchodilator FEV1 < 25%; Intermittent oxygen use at home; Inability to understand simple instructions.

ClinicalTrials.gov NCT06810323