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Recruiting Phase 1 NCT05289063

Vascular Endothelial Dysfunction in Sleep Apnea

Trial Parameters

Condition Obstructive Sleep Apnea of Adult
Sponsor Columbia University
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 110
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-10-03
Completion 2027-02-28
Interventions
Atorvastatin 10mgPlaceboContinuous Positive Airway Pressure Therapy

Brief 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).

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

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