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Recruiting NCT05289063

Vascular Endothelial Dysfunction in Sleep Apnea

Phase I Interventional Obstructive Sleep Apnea of Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Atorvastatin 10mg, Placebo, Continuous Positive Airway Pressure Therapy.
Who it may be relevant to
Registry conditions: Obstructive Sleep Apnea of Adult. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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).

Detailed description

Obstructive sleep apnea (OSA), a condition that affects a quarter of American adults, triples the risk for cardiovascular diseases and increases all-cause mortality. Standard therapy with continuous positive airway pressure (CPAP) does not improve cardiovascular risk. Based on the investigators' mechanistic observation that the abnormal cycle of endothelial inflammation can be disrupted with statin therapy, the investigators now propose randomized clinical trial of statins vs. placebo to determine its effects on endothelial dysfunction in OSA patients treated with CPAP, which may provide the basis for practical clinical trials of statins for reducing cardiovascular risk in OSA.

Interventions

  • Drug Atorvastatin 10mg
    Atorvastatin 10 mg daily for 28 days will be randomly allocated to OSA patients regardless of adherence with CPAP. Atorvastatin and placebo will be encapsulated to appear identical and dispensed by the research pharmacy.
  • Drug Placebo
    Placebo daily for 28 days will be randomly allocated to OSA patients regardless of adherence with CPAP. Atorvastatin and placebo will be encapsulated to appear identical and dispensed by the research pharmacy.
  • Other Continuous Positive Airway Pressure Therapy
    CPAP is a standard of care for OSA and will be prescribed by care providers not associated with this study based on clinical indications. The investigators will have no role in prescribing CPAP.

Primary outcome measures

  • Circulating levels of Angiopoietin-2 after 4 weeks of atorvastatin vs. placebo therapy [Time frame: 4 weeks post-treatment]
  • 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 [Time frame: 4 weeks post-treatment]
Secondary outcome measures (10)
  • Circulating levels of von Willebrand factor cleavage products after 4 weeks of atorvastatin vs. placebo [Time frame: 4 weeks post-treatment]
  • Circulating levels of von Willebrand factor (vWF) cleavage products (low, medium, high molecular weight) at baseline and after 4 weeks of CPAP [Time frame: 4 weeks post-CPAP]
  • Endothelial cell free cholesterol levels after 4 weeks of atorvastatin vs. placebo [Time frame: 4 weeks post-treatment]
  • Endothelial cell lipid droplets after 4 weeks of atorvastatin vs. placebo [Time frame: 4 weeks post-treatment]
  • Endothelial cell interactions between CD59 and Weibel Palade Bodies (WPBs) after 4 weeks of atorvastatin vs. placebo [Time frame: 4 weeks post-treatment]
  • Circulating levels of Angiopoietin-2 at baseline and after 4 weeks of CPAP therapy [Time frame: 4 weeks post-CPAP]
  • Interaction of ER-bound VAPB with late endosome-bound ORP1L (proximity ligation assay fluorescence area in µm2) at baseline and after 4 weeks of CPAP therapy [Time frame: 4 weeks post-CPAP]
  • Endothelial cell nuclear factor kappa B (NF-κB) nuclear fluorescence intensity after 4 weeks of atorvastatin vs. placebo [Time frame: 4 weeks post-treatment]
  • Circulating levels of E-selectin after 4 weeks of atorvastatin vs. placebo therapy [Time frame: 4 weeks post-treatment]
  • Endothelial cell messenger ribonucleic acid (mRNA) expression of EC adhesion molecules after 4 weeks of atorvastatin vs. placebo [Time frame: 4 weeks post-treatment]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Columbia University Irving Medical Center — New York

Identifiers

NCT: NCT05289063 · AAAT8810 · 2R01HL106041

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗