Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin (StatinflaSAS)

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Terminated; Phase 2

Conditions: Obstructive Sleep Apnea Syndrome

Treatments: Other: CPAP device; Other: sham CPAP treatment; Drug: Atorvastatin treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT00669695

0721

2007-005286-35 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

54 participants in 4 patient groups, including a placebo group

Stat/CPAP

Placebo Comparator group

Description:

Atorvastatin and CPAP treatments

Treatment:

Drug: Atorvastatin treatment

Other: CPAP device

Stat/sham CPAP

Placebo Comparator group

Description:

Atorvastatin and sham CPAP treatments

Treatment:

Drug: Atorvastatin treatment

Other: sham CPAP treatment

Placebo/CPAP

Sham Comparator group

Description:

Placebo and CPAP treatments

Treatment:

Other: CPAP device

Placebo/sham CPAP

Active Comparator group

Description:

Placebo and sham CPAP treatments

Treatment:

Other: sham CPAP treatment