Obstructive Sleep Apnea Syndrome
Conditions
Keywords
statins, cardiovascular risk, Obstructive sleep apnea syndrome (OSAS) patients
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.
Interventions
Atorvastatin treatment: tablets of 40 mg Atorvastatin will be administered orally, respecting the dosage of 40 mg/day, for 6 months.
OTHERCPAP device
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.
OTHERsham CPAP treatment
This device consists in a sham CPAP. It will be applied 3 months after the beginning of drug treatment and for 3 months.
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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. |
Countries
France, Switzerland
Outcome results
None listed