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Statins

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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
+7 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: TreatmentActive Control2 Interventions
OSA patients who adhered or did not adhere with CPAP who are randomized to receive atorvastatin 10 mg daily.
Group II: ControlPlacebo Group2 Interventions
OSA patients who adhered or did not adhere with CPAP who are randomized to receive placebo daily.

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,850,788 Total Patients Enrolled
Columbia UniversityLead Sponsor
1,432 Previous Clinical Trials
2,460,863 Total Patients Enrolled
Sanja Jelic, MDPrincipal InvestigatorColumbia University
4 Previous Clinical Trials
354 Total Patients Enrolled

Media Library

Atorvastatin (Statins) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05289063 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has recruitment for this research commenced?

"The information on clinicaltrials.gov reveals that participant recruitment for this medical test has concluded. It was first posted in September 1st 2022 and edited lastly March 11th 2022. However, there are currently 291 other clinical trials seeking volunteers at the present time."

Answered by AI

Has the FDA sanctioned this medical regimen?

"As this is a preliminary clinical trial, our Power team gives the safety of this treatment an initial score of 1 due to limited data indicating its efficacy and lack of verifiable evidence for its security."

Answered by AI

What purpose is this clinical trial seeking to fulfill?

"This clinical trial will closely assess the circulating levels of Angiopoietin-2 over 4 weeks post-treatment to measure its primary outcome. Secondary objectives include measuring endothelial cell lipid droplets, free cholesterol quantities, and VAPB proximity with ORP1L through a ligation assay in order to evaluate CPAP therapy's effectiveness after four weeks."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
What site did they apply to?
Columbia University Irving Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I've stopped using my CPAP because of the inconvenience, but my wife said I'm snoring as much as ever.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Vascular Endothelial Dysfunction in Sleep Apnea
Sanja Jelic 2022. "Vascular Endothelial Dysfunction in Sleep Apnea". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05289063.
All > Apnea > Lipitor
~60 spots leftby Feb 2026
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