Atorvastatin + CPAP for Sleep Apnea

Phase 1

Recruiting

Led By Sanja Jelic, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks post-cpap

Awards & highlights

All Individual Drugs Already Approved

Approved for 30 Other Conditions

Summary

This trial will test whether atorvastatin reduces levels of inflammatory markers in OSA patients treated with CPAP.

Who is the study for?

This trial is for adults over 18 newly diagnosed with obstructive sleep apnea (OSA), characterized by frequent interruptions in breathing during sleep. Participants should not have used CPAP therapy before and must not be on regular medications or have a history of serious heart, lung, kidney diseases, diabetes, cancer, muscle issues or smoking recently.

What is being tested?

The study tests if taking Atorvastatin (a cholesterol-lowering medication) for four weeks reduces inflammation related to OSA in patients also using CPAP therapy. It's a randomized trial where some get the real medicine while others get a placebo without knowing which one they're receiving.

What are the potential side effects?

Atorvastatin may cause side effects like muscle pain or weakness, fatigue, headache, digestive problems and possible increased risk of diabetes. The CPAP device might lead to discomfort in the face area due to its mask.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been newly diagnosed with sleep apnea and have not used CPAP.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks post-cpap

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks post-cpap

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks post-cpap for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Circulating levels of Angiopoietin-2 after 4 weeks of atorvastatin vs. placebo therapy

Interaction of endoplasmic reticulum (ER)-bound vesicle-associated membrane protein-associated protein B (VAPB) with late endosome-bound ORP1L (proximity ligation assay fluorescence area in µm2) after 4 weeks of atorvastatin vs. placebo therapy

Secondary study objectives

Circulating levels of Angiopoietin-2 at baseline and after 4 weeks of CPAP therapy

Circulating levels of E-selectin after 4 weeks of atorvastatin vs. placebo therapy

Circulating levels of von Willebrand factor (vWF) cleavage products (low, medium, high molecular weight) at baseline and after 4 weeks of CPAP

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