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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 April 22, 2025

Not yet recruiting

Keywords

Oxygen Therapy Copd

ClinConnect Summary

This clinical trial will be a conventional randomized, parallel controlled trial to evaluate the primary hypothesis that a 4-week period of using the ROAM adherence monitor and support system will result in increased adherence when compared to a control group with no adherence monitoring. The participant population will be individuals with chronic obstructive pulmonary disease (COPD), and who have been prescribed oxygen therapy for a minimum of 8 hours/day. Half of the participants will be randomly assigned to the ROAM group; the other half will comprise the control group.

All participants...

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

Trial Officials

Eileen Krepkovich, MS

Principal Investigator

Barron Associates

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported