Respiratory Oxygen Adherence Monitor for Chronic Obstructive Pulmonary Disease Patients

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
Barron Associates, Inc.
Study ID
NCT06874101
Status
Not Yet Recruiting

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Conditions

  • COPD
  • COPD - Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Activated ROAM System with User Feedback — DEVICE
    The activated ROAM device will provide the user with daily information about their oxygen therapy usage and pulse oximetry.
  • Sham Comparator — DEVICE
    The sham comparator is a ROAM device that monitors oxygen usage, but keeps the usage details blind to the user.

Study Details

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.

Key Dates

Start date
May 1, 2025
Status verified
Mar 2025
Primary completion
Apr 1, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: ROAM Group
    The ROAM group participants will have access to the ROAM user feedback display on their concentrator and portable tank oxygen delivery systems, throughout the 4-week study duration.
  • Sham Comparator: Control Group
    The control group participants will have their oxygen delivery concentrators and portable tanks fitted with the ROAM system, which will monitor their usage, but they will not receive any of the user feedback or have access to the ROAM software.

Primary Outcome Measure

Adherence rates of oxygen therapy [ Time Frame: From enrollment through completion of the study at 5 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22903
Yun Shim, MD
[email protected]
434-924-5219
Yun Shim, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Charlottesville, VA

By condition
COPD
By specialty
PulmonologyLung disease
By research site
University of Virginia· Charlottesville, VA

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