Overview

The Cardiovascular Consequences of Sleep Apnea Plus COPD (Overlap Syndrome)

Status:
Not yet recruiting

Trial end date:
2027-08-31

Target enrollment:
0

Participant gender:
All

Summary

Aim 1: We will perform a cross-sectional study to examine vascular risk in individuals with OVS compared with matched individuals with OSA alone or COPD alone. We 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 us 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 us to compare the magnitude of the effect of OSA vs. COPD vs OVS for design of subsequent basic and clinical studies. Aim 2: We 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). We 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 us 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.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of California, San Diego

Criteria

Inclusion Criteria:

- BMI 24-32

- OSA

- COPD

Exclusion Criteria:

- Medically unstable individuals with significant neurological disease

- Smokers

- Cardiovascular disease

- Epworth Sleepiness score over 18

- Kidney Disease