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NOT YET RECRUITING
NCT06874101
NA

Respiratory Oxygen Adherence Monitor for Chronic Obstructive Pulmonary Disease Patients

Sponsor: Barron Associates, Inc.

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-05-01

Completion Date

2026-04-30

Last Updated

2025-03-13

Healthy Volunteers

No

Interventions

DEVICE

Activated ROAM System with User Feedback

The activated ROAM device will provide the user with daily information about their oxygen therapy usage and pulse oximetry.

DEVICE

Sham Comparator

The sham comparator is a ROAM device that monitors oxygen usage, but keeps the usage details blind to the user.

Locations (1)

University of Virginia

Charlottesville, Virginia, United States