Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin - Full Text View

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

Drug Information available for: Atorvastatin Atorvastatin calcium Atorvastatin calcium trihydrate

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 ]


Enrollment:	54
Study Start Date:	May 2008
Study Completion Date:	February 2013
Primary Completion Date:	February 2013 (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 (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669695

Locations


France
Universitary Hospital of Angers
Angers, France, 49033
Hospital of Annemasse
Annemasse, France, 74017
University Hospital of Grenoble
Grenoble, France, 38043
Switzerland
Universitary Hospital of Geneva
Geneva, Switzerland, 1211

Sponsors and Collaborators

University Hospital, Grenoble

Investigators


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

More Information

Publications:

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Joyeux-Faure M, Tamisier R, Baguet JP, Dias-Domingos S, Perrig S, Leftheriotis G, Janssens JP, Trzepizur W, Launois SH, Stanke-Labesque F, Lévy 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.


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:	September 23, 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:


Syndrome Inflammation Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Disease Pathologic Processes Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Sleep Disorders, Intrinsic	Dyssomnias Sleep Wake Disorders Nervous System Diseases Atorvastatin Calcium Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 23, 2016

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