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Search / Trial NCT06874101

Respiratory Oxygen Adherence Monitor for Chronic Obstructive Pulmonary Disease Patients

Launched by BARRON ASSOCIATES, INC. · Mar 7, 2025

Trial Information

Current as of May 09, 2025

Not yet recruiting

Keywords

Oxygen Therapy Copd

ClinConnect Summary

This clinical trial is studying a device called "ROAM" designed for patients with chronic obstructive pulmonary disease (COPD) who use oxygen therapy at home. The main goal is to see if feedback from the ROAM device can help patients stick to their oxygen therapy better over a period of five weeks. Participants will be divided into two groups: one will receive information about their oxygen use and another will not. The researchers want to find out if having this feedback improves how often patients use their oxygen as prescribed.

To be eligible for the trial, participants should be adults aged 70 and older who have a diagnosis of COPD and are using continuous oxygen therapy at home. They should not have had any recent health issues, like hospitalizations or respiratory infections, in the past six weeks. During the study, participants will use their oxygen as usual while wearing the ROAM device and will visit the clinic twice to complete some questionnaires about their experience. This trial is not yet recruiting, but it aims to help improve oxygen therapy adherence for COPD patients in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Post-Bronchodilator FEV1/FVC\<.80
  • Participants with medical history of COPD
  • 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/FVC ≤25%
  • Intermittent oxygen use at home
  • Inability to understand simple instructions
  • Respiratory exacerbation or infections within 6 weeks prior to screen visit
  • Not at baseline of medical health prior to screen visit

About Barron Associates, Inc.

Barron Associates, Inc. is a leading clinical trial sponsor dedicated to advancing medical research and innovation. With a commitment to excellence, the company specializes in the design, management, and execution of clinical trials across various therapeutic areas. Leveraging a team of experienced professionals and state-of-the-art technology, Barron Associates focuses on enhancing patient outcomes and ensuring regulatory compliance throughout the research process. Their collaborative approach fosters strong partnerships with healthcare providers, regulatory bodies, and research institutions, ultimately driving the development of safe and effective medical solutions.

Locations

Charlottesville, Virginia, United States

Patients applied

0 patients applied

Trial Officials

Eileen Krepkovich, MS

Principal Investigator

Barron Associates

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported