The ROAM Research Study Therapy (LTOT) Version

Recruiting

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT06810323
• Lead Sponsor: University of Virginia

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.

Study Timeline

• Study First Submitted: 2024-11-15
• Status Verified: 2025-01
• Study Start: 2025-01-14
• Study First Submitted QC: 2025-01-30
• Last Update Submitted: 2025-01-30
• Study First Posted: 2025-02-05
• Last Update Posted: 2025-02-05
• Primary Completion: 2028-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In lab validation study to confirm operation of the device	2 hour	Repeatability and correlation of the device compared to standard clinical device (pulse ox and heart rate)

Secondary Outcome Measures

Name	Time	Method
Overnight sleep lab testing while wearing the device to correlate the accuracy of the ROAM device using sleep study results.	Overnight ( 8-12 hours)	Test the performance of the ROAM device overnight.
Long-term ROAM device testing (4 weeks)	4 weeks	Testing the ROAM device in an ambulatory setting and follow-up after 2 weeks and return the device after 4 weeks.

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States