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Respiratory Oxygen Adherence Monitor for Chronic Obstructive Pulmonary Disease Patients

NCT06874101 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-03-13

No results posted yet for this study

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.

Conditions

  • COPD
  • COPD - Chronic Obstructive Pulmonary Disease

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.

Sponsors & Collaborators

  • University of Virginia

    collaborator OTHER

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Barron Associates, Inc.

    lead INDUSTRY

Principal Investigators

  • Eileen Krepkovich, MS · Barron Associates

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2026-04-01
Completion
2026-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06874101 on ClinicalTrials.gov