Vascular Endothelial Dysfunction in Sleep Apnea

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Description

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).

Study Overview

Start Date
October 3, 2022
Completion Date
February 28, 2026
Enrollment
110
Date Posted
March 21, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Columbia University Irving Medical Center
New York, New York 10032, United States

Eligibility

Minimum Age (years)
18
Eligibility Criteria
Inclusion Criteria:

Aged ≥18 years
Newly diagnosed with obstructive sleep apnea (OSA) who were never treated with CPAP. OSA is defined as apnea-hypopnea index (AHI) ≥5 events/hour of sleep.

Exclusion Criteria:

A history of coronary artery disease, heart failure, stroke, diabetes, malignancy, chronic pulmonary, kidney or rheumatologic disease, muscle pain/fatigue, smoking within the past 5 years
Regular use of any medications

Study Contact Info

Study Contact Name
Sanja Jelic, MD
Study Contact Email
Study Contact Phone

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Other Details

FDA Regulated Drug?
Yes
FDA Regulated Device?
No
Detailed 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.
NCTid (if applicable)
NCT05289063