Recruiting

LTOT

Sponsor:

University of Virginia

Code:

NCT06810323

Conditions

Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06810323

Start date

Jan 14, 2025

Status verified date

Jan, 2025

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • In lab validation study to confirm operation of the device [ Time Frame: 2 hour ]

Central Contacts and Locations

Central contacts

Roselove NUNOO-ASARE, MA

434-243-6074RNN3B@VIRGINIA.EDU

Carol Bampoe, BS

cb3ff@virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Roselove Nunoo-Asare, MA

434-243-6074RNN3B@VIRGINIA.EDU

Principal Investigator:

Yun M Shim, MD

More Information

Sponsor

University of Virginia

Last update posted

Feb 5, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2025-02-05.