Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin

Phase 2

Terminated

• Conditions: Obstructive Sleep Apnea Syndrome
• Interventions: Drug: Atorvastatin treatment; Other: CPAP device; Other: sham CPAP treatment

• Registration Number: NCT00669695
• Lead Sponsor: University Hospital, Grenoble

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.

Study Timeline

• Study First Submitted: 2008-04-21
• Study First Submitted QC: 2008-04-28
• Study First Posted: 2008-04-30
• Study Start: 2008-05
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-23
• Last Update Posted: 2013-09-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stat/CPAP	Atorvastatin treatment	Atorvastatin and CPAP treatments
Placebo/CPAP	CPAP device	Placebo and CPAP treatments
Stat/CPAP	CPAP device	Atorvastatin and CPAP treatments
Stat/sham CPAP	Atorvastatin treatment	Atorvastatin and sham CPAP treatments
Placebo/sham CPAP	sham CPAP treatment	Placebo and sham CPAP treatments
Stat/sham CPAP	sham CPAP treatment	Atorvastatin and sham CPAP treatments

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Evaluation of the insulin-resistance associated to OSAS.	after 3 months of Atorvastatin or placebo treatment.
Measurement of the CPAP efficiency in comparison with sham CPAP in patients receiving the placebo.	after 3 months of treatment.
Evaluation of the inflammation occurring during OSAS.	after 3 months of Atorvastatin or placebo treatment.

Trial Locations

Locations (4)

Universitary Hospital of Angers; 🇫🇷 Angers, France

University Hospital of Grenoble; 🇫🇷 Grenoble, France

Universitary Hospital of Geneva; 🇨🇭 Geneva, Switzerland

Hospital of Annemasse; 🇫🇷 Annemasse, France