Obstructive Sleep Apnea Syndrome Clinical Trial
Official title:
Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin
The aim of this clinical trial is to evaluate the effect of Atorvastatin on the endothelial
function improvement during the obstructive sleep apnea syndrome (OSAS) after 3 months of
treatment, by a double-blind, randomized, placebo-controlled, multi-center study.
An interim analysis will be performed when 25 patients per group will be included.
Secondary objectives of this clinical trial :
- To evaluate the effect of Atorvastatin in comparison with the placebo on the
inflammation occurring during OSAS, after 3 months of treatment.
- To evaluate the effect of Atorvastatin in comparison with the placebo on the
insulin-resistance associated to OSAS, after 3 months of treatment.
- To evaluate the effect of Atorvastatin in comparison with the placebo on the
hypercholesterolemia associated to OSAS, after 3 months of treatment.
- To evaluate at 6 months, the effect of the continuous positive airway pressure (CPAP) +
Atorvastatin association on the previously cited parameters, in comparison with
Atorvastatin, CPAP and placebo.
- To measure the CPAP efficiency in comparison with sham CPAP in patients receiving the
placebo, after 3 months of treatment.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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