Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin

Obstructive Sleep Apnea Syndrome Clinical Trial

— StatinflaSAS  

Official title:

Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00669695
• Other study ID #: 0721
• Secondary ID: 2007-005286-35
• Status: Terminated
• Phase: Phase 2
• First received: April 21, 2008
• Last updated: September 23, 2013
• Start date: May 2008
• Est. completion date: February 2013

Study information

• Verified date: September 2013
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

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 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.
• 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.

Locations

Country	Name	City	State
France	Universitary Hospital of Angers	Angers
France	Hospital of Annemasse	Annemasse
France	University Hospital of Grenoble	Grenoble
Switzerland	Universitary Hospital of Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Countries where clinical trial is conducted

France,  Switzerland, 

References & Publications (1)

Bergeron C, Kimoff J, Hamid Q. Obstructive sleep apnea syndrome and inflammation. J Allergy Clin Immunol. 2005 Dec;116(6):1393-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the percent of peripheral arterial tone (PAT) improvement in comparison with the baseline situation.		after 3 months of Atorvastatin treatment.	Yes
Secondary	Evaluation of the inflammation occurring during OSAS.		after 3 months of Atorvastatin or placebo treatment.	Yes
Secondary	Evaluation of the insulin-resistance associated to OSAS.		after 3 months of Atorvastatin or placebo treatment.	Yes
Secondary	Evaluation of the hypercholesterolemia associated to OSAS.		after 3 months of Atorvastatin or placebo treatment.	Yes
Secondary	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	Yes
Secondary	Measurement of the CPAP efficiency in comparison with sham CPAP in patients receiving the placebo.		after 3 months of treatment.	Yes