The ROAM Research Study Therapy (LTOT) Version

NCT06810323 | Recruiting

• 1 other identifier: 231682
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• 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)

  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.

  Overnight ( 8-12 hours)

• Long-term ROAM device testing (4 weeks)

  4 weeks

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 COPD subjects with continuous oxygen wear

You may qualify if:

• 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

You may not qualify if:

• Post -Bronchodilator FEV1 \< 25%
• Intermittent oxygen use at home
• Inability to understand simple instructions
• No respiratory infections and exacerbation within 6 weeks of study

Sponsors & Collaborators

• University of Virginia: lead
• Barron Associates, Inc.: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yun M Shim, MD

  Division of Pulmonary and Critical Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roselove NUNOO-ASARE, MA

CONTACT

434-243-6074; RNN3B@VIRGINIA.EDU

Carol Bampoe, BS

CONTACT

cb3ff@virginia.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Medicine-Pulmonary and Critical Care Medicine

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: February 5, 2025
• Study Start: January 14, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 5, 2025

Record last verified: 2025-01

Locations

US (1)