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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
Atorvastatin treatment: tablets of 40 mg Atorvastatin will be administered orally, respecting the dosage of 40 mg/day, for 6 months.
This device consists in a nasal continuous positive airway pressure (CPAP). It will be applied 3 months after the beginning of drug treatment and for 3 months.
This device consists in a sham CPAP. It will be applied 3 months after the beginning of drug treatment and for 3 months.
Universitary Hospital of Angers
Angers, France
Hospital of Annemasse
Annemasse, France
University Hospital of Grenoble
Grenoble, France
Universitary Hospital of Geneva
Geneva, Switzerland
The primary endpoint is the percent of peripheral arterial tone (PAT) improvement in comparison with the baseline situation.
Time frame: after 3 months of Atorvastatin treatment.
Evaluation of the inflammation occurring during OSAS.
Time frame: after 3 months of Atorvastatin or placebo treatment.
Evaluation of the insulin-resistance associated to OSAS.
Time frame: after 3 months of Atorvastatin or placebo treatment.
Evaluation of the hypercholesterolemia associated to OSAS.
Time frame: after 3 months of Atorvastatin or placebo treatment.
Evaluation of the effect of continuous positive airway pressure (CPAP) + Atorvastatin association on the previously cited parameters, in comparison with effect of Atorvastatin, CPAP and placebo.
Time frame: after 6 months of treatments
Measurement of the CPAP efficiency in comparison with sham CPAP in patients receiving the placebo.
Time frame: after 3 months of treatment.
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