Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin

Conditions
-----------------
Obstructive Sleep Apnea Syndrome

Intervention / Treatment
-----------------
* Drug: Atorvastatin treatment
* Other: CPAP device
* Other: sham CPAP treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women > 18 years old Subjects diagnosed with OSAS (apnea/hypopnea index = AHI > 30/h) Subjects with clinical ATH from grade I or II controlled with mono-therapy(140<SAP<180 mmHg and 90<DAP<110 mmHg) Exclusion Criteria: Patients with a history of prior stroke or coronary ischemic disease Chronic respiratory disease (PaO2 < 60 mmHg and/or PaCO2 > 45 mmHg) Lung disease Hypothyroidism Statin treatment Antihypertensive treatment with more than one drug Pregnant or lactating women Alcohol consumption > 3 units/day Treatment by itraconazole, ketoconazole, antiprotease, fibrates, antivitamin K, diltiazem, verapamil, erythromycin, clarithromycin, cyclosporin. Hypersensitivity to one of the drug compounds Patients with modified concomitant treatments during the 3 months before inclusion Potentially dangerous sleepiness Jobs at risk

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Stat/CPAP<br>Atorvastatin and CPAP treatments | Drug: Atorvastatin treatment<br>* Atorvastatin treatment: tablets of 40 mg Atorvastatin will be administered orally, respecting the dosage of 40 mg/day, for 6 months.<br>* Other names: statin;Other: CPAP device<br>* 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.<br>* Other names: positive air way pressure;|
| Placebo Comparator: Stat/sham CPAP<br>Atorvastatin and sham CPAP treatments | Drug: Atorvastatin treatment<br>* Atorvastatin treatment: tablets of 40 mg Atorvastatin will be administered orally, respecting the dosage of 40 mg/day, for 6 months.<br>* Other names: statin;Other: sham CPAP treatment<br>* This device consists in a sham CPAP. It will be applied 3 months after the beginning of drug treatment and for 3 months.<br>* Other names: sham CPAP;|
| Sham Comparator: Placebo/CPAP<br>Placebo and CPAP treatments | Other: CPAP device<br>* 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.<br>* Other names: positive air way pressure;|
| Active Comparator: Placebo/sham CPAP<br>Placebo and sham CPAP treatments | Other: sham CPAP treatment<br>* This device consists in a sham CPAP. It will be applied 3 months after the beginning of drug treatment and for 3 months.<br>* Other names: sham CPAP;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the percent of peripheral arterial tone (PAT) improvement in comparison with the baseline situation. |  | after 3 months of Atorvastatin treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the inflammation occurring during OSAS. |  | after 3 months of Atorvastatin or placebo treatment. | 
| Evaluation of the insulin-resistance associated to OSAS. |  | after 3 months of Atorvastatin or placebo treatment. | 
| Evaluation of the hypercholesterolemia associated to OSAS. |  | 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. |  | after 6 months of treatments | 
| Measurement of the CPAP efficiency in comparison with sham CPAP in patients receiving the placebo. |  | after 3 months of treatment. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
statins, cardiovascular risk, Obstructive sleep apnea syndrome (OSAS) patients