Effects of atorvastatin on inflammation in sleep apnea patients
Vascular Endothelial Dysfunction in Sleep Apnea
This study is testing if taking atorvastatin daily can lower inflammation in people with obstructive sleep apnea who are using CPAP therapy.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05289063 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate whether a daily dose of atorvastatin can reduce inflammatory markers in patients with obstructive sleep apnea (OSA) who are being treated with continuous positive airway pressure (CPAP). The study employs a double-blind, placebo-controlled design over a period of four weeks, focusing on two main objectives: the impact of statins on endothelial inflammation and pro-thrombotic conditions, and their effect on endothelial cholesterol metabolism in OSA patients. By investigating these factors, the study seeks to provide insights into potential cardiovascular risk reduction strategies for individuals with OSA.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have recently been diagnosed with obstructive sleep apnea and have not previously received CPAP treatment.
Not a fit: Patients with a history of coronary artery disease, heart failure, stroke, diabetes, malignancy, or other significant chronic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular health for patients with obstructive sleep apnea.
How similar studies have performed: Previous studies have suggested that statins may have beneficial effects on cardiovascular risk factors, but this specific approach in OSA patients is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Sanja Jelic, MD — Columbia University
- Study coordinator: Sanja Jelic, MD
- Email: sj366@cumc.columbia.edu
- Phone: 2125438875
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.