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NCT06874101Not yet recruiting

Respiratory Oxygen Adherence Monitor for Chronic Obstructive Pulmonary Disease Patients

Evaluating a Respiratory Oxygen Adherence Monitor for COPD Patients With Long-term Oxygen Therapy

Source: ClinicalTrials.gov · Last updated 13 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The goal of this clinical trial is to test a device called "ROAM" that is being developed to see how patients with chronic obstructive pulmonary disease (COPD) use oxygen therapy over a long period of time. This study will focus on evaluating the ROAM device, which will be attached to your oxygen source. The question that the study aims to answer is: will patients who receive daily adherence feedback from the ROAM have increased adherence to their prescribed long term oxygen therapy regimens? Researchers will compare the amount of time using oxygen and attitudes about oxygen therapy observed in a group that receives feedback from ROAM, and a control group that does not receive feedback. Participants will have their oxygen supplies fitted with the ROAM device and then use their oxygen as usual for the 5-week study duration. Participants in the study group will have access to information about their oxygen usage and pulse oximetry levels. All participants will attend two in-clinic sessions of about an hour each, and will complete questionnaires at the beginning and end of the study.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
26 Feb 2025
Start date
1 May 2025
Primary completion date
1 Apr 2026
Lead sponsor
Barron Associates, Inc.
Diseases
COPD
NCT number
NCT06874101

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 1 May 2025 to the primary completion date, 1 Apr 2026
  • 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.

Prior treatment

  • Respiratory exacerbation or infections within 6 weeks prior to screen visit
  • Not at baseline of medical health prior to screen visit

Other

  • Post -Bronchodilator FEV1/FVC ≤25%
  • Intermittent oxygen use at home
  • Inability to understand simple instructions

Who the study is looking for

  • Post-Bronchodilator FEV1/FVC\<.80
  • Participants with medical history of COPD
  • 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

Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Virginia
Coordinator of this site? Confirm its status
CharlottesvilleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.