Vascular Endothelial Dysfunction in Sleep Apnea

Obstructive Sleep Apnea of Adult Clinical Trial

Official title: Vascular Endothelial Dysfunction in Sleep Apnea

Status Recruiting

Clinical Trial Summary

This double-blind placebo-controlled parallel group randomized study design will be used to test whether 4 weeks of atorvastatin 10 mg daily reduces levels of inflammatory markers in OSA patients treated with CPAP (standard of care). The purpose of this study is to investigate: 1) whether statins reduce endothelial inflammation and pro-thrombotic conditions in OSA, including in patients adherent to CPAP (Aim 1); and 2) whether statins reduce endothelial inflammation and pro-thrombotic conditions by improving endothelial cholesterol metabolism and trafficking in OSA (Aim 2).

Clinical Trial Description

Obstructive sleep apnea (OSA), a condition that affects a quarter of American adults, triples the risk for cardiovascular diseases and increases all-cause mortality. Standard therapy with continuous positive airway pressure (CPAP) does not improve cardiovascular risk. Based on the investigators' mechanistic observation that the abnormal cycle of endothelial inflammation can be disrupted with statin therapy, the investigators now propose randomized clinical trial of statins vs. placebo to determine its effects on endothelial dysfunction in OSA patients treated with CPAP, which may provide the basis for practical clinical trials of statins for reducing cardiovascular risk in OSA. ;

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea of Adult
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

• NCT number: NCT05289063
• Study type: Interventional
• Source: Columbia University
• Contact: Sanja Jelic, MD
• Phone: 2125438875
• Email: sj366@cumc.columbia.edu
• Status: Recruiting
• Phase: Phase 1
• Start date: October 3, 2022
• Completion date: February 28, 2026