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

This study is currently recruiting participants.
Verified January 2013 by University Hospital, Grenoble
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00669695
First received: April 21, 2008
Last updated: January 24, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Obstructive Sleep Apnea Syndrome
 Drug: Atorvastatin treatment
Other: CPAP device
Other: sham CPAP treatment
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea Statins
U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

Primary Outcome 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluation of the inflammation occurring during OSAS. [ Time Frame: after 3 months of Atorvastatin or placebo treatment. ] [ Designated as safety issue: Yes ]
  • Evaluation of the insulin-resistance associated to OSAS. [ Time Frame: after 3 months of Atorvastatin or placebo treatment. ] [ Designated as safety issue: Yes ]
  • Evaluation of the hypercholesterolemia associated to OSAS. [ Time Frame: after 3 months of Atorvastatin or placebo treatment. ] [ Designated as 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 ] [ Designated as 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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: May 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Stat/CPAP
Atorvastatin and CPAP treatments
 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 Name: statin
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.
Other Name: positive air way pressure
Placebo Comparator: Stat/sham CPAP
Atorvastatin and sham CPAP treatments
 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 Name: statin
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.
Other Name: sham CPAP
Sham Comparator: Placebo/CPAP
Placebo and CPAP treatments
 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.
Other Name: positive air way pressure
Active Comparator: Placebo/sham CPAP
Placebo and sham CPAP treatments
 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.
Other Name: sham CPAP

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00669695

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

Locations
France
Universitary Hospital of Angers Recruiting
Angers, France, 49033
Contact: Frédéric GAGNADOUX, MD, PhD     02.41.35.36.95     FrGagnadoux@chu-angers.fr    
Sub-Investigator: Pascaline PRIOU, MD, PhD            
Sub-Investigator: Georges LEFTHERIOTIS, MD, PhD            
Sub-Investigator: Wojciech TRZEPIZUR, MD            
Hospital of Annemasse Not yet recruiting
Annemasse, France, 74017
Contact: José HABA-RUBIO, MD     33-450-874-027     Jhaba-rubio@chi-annemasse-bonneville.fr    
Sub-Investigator: José HABA-RUBIO, MD, PhD            
Sub-Investigator: Patrick CHATELLAIN, MD, PhD            
University Hospital of Grenoble Recruiting
Grenoble, France, 38043
Contact: Jean-Louis PEPIN, MD, PhD     33-476-765-516     JPepin@chu-grenoble.fr    
Principal Investigator: Jean-Louis PEPIN, MD, PhD            
Sub-Investigator: Renaud TAMISIER, MD, PhD            
Sub-Investigator: Patrick LEVY, MD, PhD            
Sub-Investigator: Jean-Philippe BAGUET, MD, PhD            
Sub-Investigator: Jean-Charles RENVERSEZ, MD, PhD            
Sub-Investigator: Patrice FAURE, MD, PhD            
Switzerland
Universitary Hospital of Geneva Recruiting
Geneva, Switzerland, 1211
Contact: François MACH, MD, PhD     41-22-382-7234     Francois.Mach@medecine.unige.ch    
Sub-Investigator: François MACH, MD, PhD            
Sub-Investigator: Stephen PERRIG, MD, PhD            
Sub-Investigator: Jean-Paul JANSSENS, MD, PhD            
Sub-Investigator: Thierry ROCHAT, MD, PhD            
Sub-Investigator: Roman SZTAJZEL, MD, PhD            
Sub-Investigator: Vicente IBANEZ, MD, PhD            
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Jean-Louis PEPIN, MD, PhD University Hospital of Grenoble, France
  More Information

Publications:

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00669695     History of Changes
Other Study ID Numbers: 0721, 2007-005286-35
Study First Received: April 21, 2008
Last Updated: January 24, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
statins
cardiovascular risk
Obstructive sleep apnea syndrome (OSAS) patients

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Inflammation
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Pathologic Processes
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
 Nervous System Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013