Clinical trial NCT00669695: Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin
Official title: Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: statins
cardiovascular risk
Obstructive sleep apnea syndrome (OSAS) patients
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2008-04-30
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The primary endpoint is the percent of peripheral arterial tone (PAT) improvement in comparison with the baseline situation.
timeFrame: after 3 months of Atorvastatin treatment.
Secondary outcomes:
measure: Evaluation of the inflammation occurring during OSAS.
timeFrame: after 3 months of Atorvastatin or placebo treatment.
measure: Evaluation of the insulin-resistance associated to OSAS.
timeFrame: after 3 months of Atorvastatin or placebo treatment.
measure: Evaluation of the hypercholesterolemia associated to OSAS.
timeFrame: after 3 months of Atorvastatin or placebo treatment.
measure: 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.
timeFrame: after 6 months of treatments
measure: Measurement of the CPAP efficiency in comparison with sham CPAP in patients receiving the placebo.
timeFrame: after 3 months of treatment.
Other outcomes:
Locations:
city: Angers
country: France
facility: Universitary Hospital of Angers
city: Annemasse
country: France
facility: Hospital of Annemasse
city: Grenoble
country: France
facility: University Hospital of Grenoble
city: Geneva
country: Switzerland
facility: Universitary Hospital of Geneva
Study officials:
affiliation: University Hospital of Grenoble, France
name: Jean-Louis PEPIN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bergeron C, Kimoff J, Hamid Q. Obstructive sleep apnea syndrome and inflammation. J Allergy Clin Immunol. 2005 Dec;116(6):1393-6. doi: 10.1016/j.jaci.2005.10.008. No abstract available.
citation: Jullian-Desayes I, Tamisier R, Zarski JP, Aron-Wisnewsky J, Launois-Rollinat SH, Trocme C, Levy P, Joyeux-Faure M, Pepin JL. Impact of effective versus sham continuous positive airway pressure on liver injury in obstructive sleep apnoea: Data from randomized trials. Respirology. 2016 Feb;21(2):378-85. doi: 10.1111/resp.12672. Epub 2015 Nov 16.
citation: Joyeux-Faure M, Tamisier R, Baguet JP, Dias-Domingos S, Perrig S, Leftheriotis G, Janssens JP, Trzepizur W, Launois SH, Stanke-Labesque F, Levy PA, Gagnadoux F, Pepin JL. Response to statin therapy in obstructive sleep apnea syndrome: a multicenter randomized controlled trial. Mediators Inflamm. 2014;2014:423120. doi: 10.1155/2014/423120. Epub 2014 Aug 25.