Pulmonary Disease, Chronic ObstructiveROAMNCT06810323
The ROAM Research Study Therapy (LTOT) Version
An observational study of Pulmonary Disease, Chronic Obstructive, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this research is to test a device being developed that can see how patients use oxygen therapy over a long period of time. This study will focus on developing a new display part called ROAM module which will be attached to your oxygen source. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2025to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 100 COPD subjects with continuous oxygen wear
Who may be able to join
- Post-Bronchodilator FEV1/FVC <.80
- Race demographics of the recruitment area reflect the population of the Charlottesville Metropolitan Statistical Area (MSA).
- Due to underrepresentation in local demographics, special effort (via targeted advertising) will be made to recruit Hispanic participants to better match national percentages.
- Participants with medical history of COPD
- Subjects has to have a 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
Who cannot join
- Post -Bronchodilator FEV1 < 25%
- Intermittent oxygen use at home
- Inability to understand simple instructions
- No respiratory infections and exacerbation within 6 weeks of study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Carol Bampoe, BS contact
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Roselove Nunoo-Asare, MA, 434-243-6074, RNN3B@VIRGINIA.EDU
Yun M Shim, MD
About this study
Official title: The Respiratory Oxygen Adherence Monitor System for COPD With Long Term Oxygen Therapy
The purpose of this research is to test a device being developed that can see how patients use oxygen therapy over a long period of time. This study will focus on developing a new display part called ROAM module which will be attached to your oxygen source. The display will provide easily-accessible information that can show how you interact with your supplies and the oxygen machine automatically without connecting the oxygen source to the internet or other devices.
Read the detailed description
The Respiratory Oxygen Adherence Monitor (ROAM) system objectively determines the duration and pattern of adherence to oxygen therapy on a minute-by-minute basis and provides feedback of usage metrics to patients and their clinicians. The purpose of the ROAM monitor is, ultimately, to improve the clinical management of patients with chronic obstructive pulmonary disease (COPD) and patients requiring long-term oxygen therapy (LTOT), to improve health outcomes in these patients, and to reduce costs that arise from the expensive and preventable exacerbations associated with patient non-adherence. The prevalence of COPD poses an enormous burden to the U.S. healthcare system. LTOT is a well-established treatment for patients with oxygen desaturation due to COPD and other cardiopulmonary diseases. The benefits of adequate adherence to LTOT are substantial both to COPD patients (in terms of reduced morbidity and mortality) and to society (in terms of healthcare cost savings). Despite these benefits, patient adherence to LTOT remains poor. The lack of a method to objectively and reliably quantify LTOT usage complicates the challenge of managing these patients. Furthermore, current adherence metrics (e.g., power-on time) fail to provide information regarding the timing of oxygen use within each 24-hour interval. The ROAM system combines several unobtrusive sensing modalities with adaptive algorithms that detect breathing. In this study, the team will develop a patient-ready product prototype targeted at improving patient LTOT adherence.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
In lab validation study to confirm operation of the device
Repeatability and correlation of the device compared to standard clinical device (pulse ox and heart rate)
Measured: 2 hour
Secondary outcomes (2)
Overnight sleep lab testing while wearing the device to correlate the accuracy of the ROAM device using sleep study results.
Test the performance of the ROAM device overnight.
Measured: Overnight ( 8-12 hours)
Long-term ROAM device testing (4 weeks)
Testing the ROAM device in an ambulatory setting and follow-up after 2 weeks and return the device after 4 weeks.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start14 Jan 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Barron Associates, Inc.
- Responsible party
- Principal investigator, Y. Michael Shim, MD, University of Virginia
- Investigators
- Yun M Shim, MD, Principal investigator, Division of Pulmonary and Critical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810323
- Sponsor's protocol ID
- 231682
- Acronym
- ROAM
- Status last verified
- Jan 2025
- First submitted
- 15 Nov 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Respiratory Oxygen Adherence Monitor System for COPD With Long Term Oxygen Therapy
- ClinicalTrials.gov ID
- NCT06810323
- Acronym / sponsor ID
- ROAM / 231682
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Barron Associates, Inc.
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to test a device being developed that can see how patients use oxygen therapy over a long period of time. This study will focus on developing a new display part called ROAM module which will be attached to your oxygen source. The display will provide easily-accessible information that can show how you interact with your supplies and the oxygen machine automatically without connecting the oxygen source to the internet or other devices.
Detailed description
The Respiratory Oxygen Adherence Monitor (ROAM) system objectively determines the duration and pattern of adherence to oxygen therapy on a minute-by-minute basis and provides feedback of usage metrics to patients and their clinicians. The purpose of the ROAM monitor is, ultimately, to improve the clinical management of patients with chronic obstructive pulmonary disease (COPD) and patients requiring long-term oxygen therapy (LTOT), to improve health outcomes in these patients, and to reduce costs that arise from the expensive and preventable exacerbations associated with patient non-adherence. The prevalence of COPD poses an enormous burden to the U.S. healthcare system. LTOT is a well-established treatment for patients with oxygen desaturation due to COPD and other cardiopulmonary diseases. The benefits of adequate adherence to LTOT are substantial both to COPD patients (in terms of reduced morbidity and mortality) and to society (in terms of healthcare cost savings). Despite these benefits, patient adherence to LTOT remains poor. The lack of a method to objectively and reliably quantify LTOT usage complicates the challenge of managing these patients. Furthermore, current adherence metrics (e.g., power-on time) fail to provide information regarding the timing of oxygen use within each 24-hour interval. The ROAM system combines several unobtrusive sensing modalities with adaptive algorithms that detect breathing. In this study, the team will develop a patient-ready product prototype targeted at improving patient LTOT adherence.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 100 COPD subjects with continuous oxygen wear
Key inclusion criteria (7 listed)
- Post-Bronchodilator FEV1/FVC <.80
- Race demographics of the recruitment area reflect the population of the Charlottesville Metropolitan Statistical Area (MSA).
- Due to underrepresentation in local demographics, special effort (via targeted advertising) will be made to recruit Hispanic participants to better match national percentages.
- Participants with medical history of COPD
- Subjects has to have a prescription for oxygen use via nasal cannula or mask at home
Key exclusion criteria (4 listed)
- Post -Bronchodilator FEV1 < 25%
- Intermittent oxygen use at home
- Inability to understand simple instructions
- No respiratory infections and exacerbation within 6 weeks of study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In lab validation study to confirm operation of the device
Time frame: 2 hour
Repeatability and correlation of the device compared to standard clinical device (pulse ox and heart rate)
2 secondary outcomes
Overnight sleep lab testing while wearing the device to correlate the accuracy of the ROAM device using sleep study results.
Time frame: Overnight ( 8-12 hours)
Long-term ROAM device testing (4 weeks)
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carol Bampoe, BS contact
Yun M Shim, MD principal investigator
Division of Pulmonary and Critical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roselove NUNOO-ASARE, MA (434-243-6074, RNN3B@VIRGINIA.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In lab validation study to confirm operation of the device (time frame: 2 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025; AzTrials last refreshed its copy on 1 Nov 2026.