Summary

Eligibility
for people ages 50-70 (full criteria)
Dates
study started
estimated completion
Principal Investigator
by Atul Malhotra, MD
Headshot of Atul Malhotra
Atul Malhotra

Description

Summary

Aim 1: The Investigators will perform a cross-sectional study to examine vascular risk in individuals with OVS compared with matched individuals with OSA alone or COPD alone. The PI will examine a panel of biomarkers including cardiac magnetic resonance imaging (right ventricular mass primary outcome), flow mediated vasodilation, plasma biomarkers (BNP, troponin, hsCRP, ST2, galectin3, miR-210). This aim will allow the team to test the hypothesis that individuals with OVS have increased vascular risk compared with matched individuals with OSA alone or COPD alone. This aim will also allow the team to compare the magnitude of the effect of OSA vs. COPD vs OVS for design of subsequent basic and clinical studies. Aim 2: The Investigators will perform an interventional study in individuals with OVS to compare the impact of bi-level therapy with that of oxygen therapy (the current standard of care). The team will assess the same panel of biomarkers as in Aim 1 to determine the impact of treatment on the observed abnormalities. This aim will allow the team to test the hypothesis that bi-level therapy is superior to oxygen in the treatment of individuals with OVS from the standpoint of right ventricular mass and other cardiovascular risk parameters/outcomes. Our assessments of biomarkers will help to define potential causal pathways for our findings and will allow determination of appropriate biomarkers for subsequent multicenter studies.

Keywords

OSA COPD Overlap Syndrome Sleep Apnea Sleep Obstructive Sleep Apnea Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Undifferentiated Connective Tissue Diseases Syndrome Bi-Level Positive Airway Pressure Oxygen gas

Eligibility

You can join if…

Open to people ages 50-70

  • BMI 24-32
  • OSA
  • COPD

You CAN'T join if...

Lead Scientist at UCSD

  • Atul Malhotra, MD
    Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 622 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT05237505
Study Type
Interventional
Participants
Expecting 300 study participants
Last Updated