Vascular Endothelial Dysfunction in Sleep Apnea

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Obstructive Sleep Apnea of Adult

In brief

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).

Key facts

Study ID

NCT05289063

Run by

Columbia University

People needed

110

Starts

2022-10-03

Expected to finish

2027-02-28

Last updated by the study team

2026-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Columbia University Irving Medical Center — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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