ROAM System for COPD

(ROAM Trial)

Overseen By Eileen Krepkovich, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Barron Associates, Inc.

Disqualifiers: Intermittent oxygen use, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called ROAM to determine if it can help people with chronic obstructive pulmonary disease (COPD) adhere to their oxygen therapy. The ROAM device attaches to the oxygen source and provides feedback on oxygen use, aiming to improve adherence to prescribed usage. The study will compare two groups: one receiving feedback from the ROAM and one not receiving feedback. Suitable candidates are those with COPD who regularly use oxygen at home and have not experienced a recent flare-up or hospital stay. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance COPD management.

Do I need to stop my current medications for the ROAM System for COPD trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on your oxygen use, so you may not need to change your other treatments, but it's best to confirm with the study team.

What prior data suggests that the ROAM device is safe for COPD patients?

Research has not provided specific safety data for the ROAM system. This device helps patients with COPD manage long-term oxygen therapy by providing feedback on oxygen use. While specific safety details are unavailable, safety monitoring systems typically check for issues. The trial focuses on the device's effectiveness, not directly on safety. However, since it is used with oxygen therapy, it likely includes routine safety checks to ensure it does not interfere with oxygen delivery. Participants using the ROAM device will have their oxygen monitored, and no evidence has shown any harmful effects from the device itself. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ROAM system for COPD because it introduces a novel way to enhance oxygen therapy. Unlike standard oxygen treatments that simply deliver oxygen, the ROAM system provides real-time user feedback on oxygen usage. This feedback could help patients optimize their oxygen therapy, potentially improving their daily management of COPD. By offering insights directly to the user, ROAM empowers patients to take a more active role in their treatment, which is a significant shift from traditional passive oxygen delivery methods.

What evidence suggests that the ROAM device is effective for improving adherence to oxygen therapy in COPD patients?

Research has shown that the ROAM device can help people with COPD adhere more effectively to their oxygen therapy plans. In this trial, participants in the ROAM group will receive feedback on their oxygen use, which is expected to enhance adherence to long-term oxygen therapy (LTOT). Studies have found that adherence to LTOT can improve health outcomes for people with lung diseases like COPD. By providing feedback, ROAM aims to simplify following oxygen plans and potentially improve overall health. ^{2 6 7 8 9}

Who Is on the Research Team?

Eileen Krepkovich, MS

Principal Investigator

Barron Associates

Are You a Good Fit for This Trial?

This trial is for people with chronic obstructive pulmonary disease (COPD) who use long-term oxygen therapy. Participants should be willing to have their oxygen supply monitored and attend two clinic sessions. Specific eligibility criteria are not provided, but typically include being diagnosed with COPD and using prescribed oxygen.

Inclusion Criteria

I haven't been hospitalized or had a health flare-up in the last 6 weeks.

I need to use oxygen all the time.

Post-Bronchodilator FEV1/FVC less than 0.80

Exclusion Criteria

Inability to understand simple instructions

Not at baseline of medical health prior to screen visit

I haven't had lung infections or worsening symptoms in the last 6 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Baseline

Participants' oxygen supplies are fitted with the ROAM device, and baseline adherence is established over one week without feedback.

1 week

1 visit (in-person)

Treatment

Participants use the ROAM device for 4 weeks. The ROAM group receives feedback on oxygen usage, while the control group does not.

4 weeks

1 visit (in-person)

Follow-up

Participants complete a questionnaire to assess attitudes toward treatment and adherence is evaluated.

1 week

What Are the Treatments Tested in This Trial?

Interventions

• ROAM

Trial Overview The study tests the 'ROAM' device's effectiveness in improving adherence to prescribed oxygen therapy among COPD patients. It compares feedback on usage from ROAM against a control group without feedback over a 5-week period, measuring time spent on oxygen and attitudes towards therapy.

How Is the Trial Designed?

Group I: ROAM Group Experimental Treatment 1 Intervention

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.

Group II: Control Group Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Barron Associates, Inc.

Lead Sponsor

Trials

11

Recruited

520+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The innovative FreeO2 system significantly improved oxygen saturation levels in COPD patients during walking, maintaining SpO2 within the target range of 92-96% more effectively than fixed oxygen flow or room air, with only 0.6% of time spent in severe desaturation compared to 23.9% and 52.2% for the other conditions.

Patients using FreeO2 were able to walk 63% further than when breathing room air, indicating that automatic oxygen adjustment not only enhances oxygenation but may also improve exercise tolerance during daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automatic Oxygen Titration During Walking in Subjects With COPD: A Randomized Crossover Controlled Study. Lellouche, F., L'Her, E., Bouchard, PA., et al.[2022]

The West Wales Adverse Drug Reaction (ADR) Profile significantly increased the identification of medication-related problems in patients with chronic respiratory diseases, with an average increase of 20.5 problems per participant compared to a decrease in the control group.

The use of the ADR Profile also led to a higher number of nursing actions taken, with a median increase of 2.5 actions per participant in the intervention group, suggesting it enhances medication management in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication monitoring in a nurse-led respiratory outpatient clinic: pragmatic randomised trial of the West Wales Adverse Drug Reaction Profile. Gabe, ME., Murphy, F., Davies, GA., et al.[2021]

EudraVigilance, the European pharmacovigilance database, has been crucial for monitoring the safety of medicines since its launch in 2001, with 50% of scientific publications using its data to describe safety issues.

Recent enhancements to EudraVigilance, including broader access to data and improved functionalities, aim to facilitate better safety monitoring and support health research, ultimately promoting the safe and effective use of medicines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection. Postigo, R., Brosch, S., Slattery, J., et al.[2021]

The RECEIVER trial demonstrated that a digital COPD support service led to high and sustained utilization among participants, with 64 out of 83 using the application regularly over an average follow-up of 78 weeks.

Participants using the digital service experienced significantly better clinical outcomes, including a longer median time to death or respiratory-related hospital admission (335 days vs 155 days in the control group) and a greater reduction in annual hospital bed days (8.12 days vs 3.38 days).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Usage and Improved Clinical Outcomes with Adoption of a COPD Digital Support Service: Key Findings from the RECEIVER Trial. Taylor, A., Cushing, A., Dow, M., et al.[2023]

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

Citations

1. withpower.com withpower.com/trial/phase-pulmonary-disease-chronic-obstructive-4-2025-b05c4

ROAM System for COPD · Info for Participants Trial Overview The study tests the 'ROAM' device's effectiveness in improving adherence to prescribed oxygen therapy among COPD patients. It compares feedback ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06810323?term=AREA%5BConditionSearch%5D(%22Pulmonary%20Disease,%20Chronic%20Obstructive%22)&rank=10

The ROAM Research Study Therapy (LTOT) Version The purpose of the ROAM monitor is, ultimately, to improve the clinical management of patients with chronic obstructive pulmonary disease (COPD) and patients ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10470466/

Remote patient monitoring strategies and wearable ... Home-based PR for COPD has been shown to be as effective as center-based PR in improving functional exercise capacity and quality of life (53), ...

4. inknowvation.com inknowvation.com/sbir/awards/nih-2019-respiratory-oxygen-adherence-monitor-copd-patients

Respiratory Oxygen Adherence Monitor for COPD Patients ... Public Health Impact: The ROAM system will increase LTOT adherence, lead to improved health outcomes for patients with cardiopulmonary disease, ...

5. highergov.com highergov.com/grant/R44HL147667/

Respiratory Oxygen Adherence Monitor for COPD Patients Public health impact: The ROAM system will increase LTOT adherence, lead to improved outcomes for patients with cardiopulmonary disease, and reduce the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06810323

The ROAM Research Study Therapy (LTOT) Version The purpose of the ROAM monitor is, ultimately, to improve the clinical management of patients with chronic obstructive pulmonary disease (COPD) ...

7. trialx.com trialx.com/clinical-trials/listings/303957/the-roam-research-study-therapy-ltot-version/

The ROAM Research Study Therapy (LTOT) Version The purpose of the ROAM monitor is, ultimately, to improve the clinical management of patients with chronic obstructive pulmonary disease (COPD) ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10517701/

Applying the Rome Proposal on Exacerbations of Chronic ... In the present study, we find no evidence that comorbid CHF would interfere significantly with the parameters included in the Rome proposal (GOLD 2023).

9. nature.com nature.com/articles/s41598-025-02952-6

A robust chronic obstructive pulmonary disease ... The proposed system aims to classify the various stages of COPD using a COPD patient dataset comprising 101 patients and 24 varied factors ...