The ROAM Research Study Therapy (LTOT) Version

NCT ID: NCT06810323

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-14
• Study Completion Date: 2030-12-31

Brief 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. 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Post -Bronchodilator FEV1 < 25%

• Intermittent oxygen use at home
• Inability to understand simple instructions
• No respiratory infections and exacerbation within 6 weeks of study

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Barron Associates, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Y. Michael Shim, MD

Professor, Medicine-Pulmonary and Critical Care Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yun M Shim, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Pulmonary and Critical Medicine

Locations

University of Virginia

Charlottesville, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Roselove NUNOO-ASARE, MA

Role: CONTACT

RNN3B@VIRGINIA.EDU

434-243-6074

Carol Bampoe, BS

Role: CONTACT

cb3ff@virginia.edu

Facility Contacts

Roselove Nunoo-Asare, MA

Role: primary

RNN3B@VIRGINIA.EDU

434-243-6074

Other Identifiers

231682

Identifier Type: -

Identifier Source: org_study_id