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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: October 2008

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 insulino-resistence 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.

Intervention(s) in this Clinical Trial

• Drug: Atorvastatin treatment
  • Atorvastatin treatment: tablets of 40 mg Atorvastatin will be administered orally, respecting the dosage of 40 mg/day, for 6 months.
• Other: CPAP treatment
  • 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.
• Other: sham 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.

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Stat/CPAP
  • Atorvastatin and CPAP treatments
• Placebo Comparator: Stat/sham CPAP
  • Atorvastatin and sham CPAP treatments
• Sham Comparator: Placebo/CPAP
  • Placebo and CPAP treatments
• Active Comparator: Placebo/sham CPAP
  • Placebo and sham CPAP treatments

Primary Measures

• 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.
    Safety Issue?: Yes

Secondary Measures

• Evaluation of the inflammation occurring during OSAS.
  • Time Frame: after 3 months of Atorvastatin or placebo treatment.
    Safety Issue?: Yes
• Evaluation of the insulino-resistence associated to OSAS.
  • Time Frame: after 3 months of Atorvastatin or placebo treatment.
    Safety Issue?: Yes
• Evaluation of the hypercholesterolemia associated to OSAS.
  • Time Frame: after 3 months of Atorvastatin or placebo treatment.
    Safety Issue?: Yes
• 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
    Safety Issue?: Yes
• Measurement of the CPAP efficiency in comparison with sham CPAP in patients receiving the placebo.
  • Time Frame: after 3 months of treatment.
    Safety Issue?: Yes

Inclusion Criteria:

• Men or women > 18 years old
• Subjects diagnosed with OSAS (apnea/hypopnea index = AHI > 30/h)

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
• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University Hospital, Grenoble

Overall Clinical Trial Officials and Contacts

Jean-Louis PEPIN, MD, PhD Principal Investigator University Hospital of Grenoble, France  

Overall Contact: Jean-Louis Pépin, MD, PhD 33-476-765-516 JPepin@chu-grenoble.fr

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00669695

Study ID Number: 0721

ClinicalTrials.gov Identifier: NCT00669695

Health Authority: France: Afssaps - French Health Products Safety Agency