Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin (StatinflaSAS)
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ClinicalTrials.gov Identifier: NCT00669695 |
Recruitment Status
:
Terminated
(Interim analysis performed without efficient results)
First Posted
: April 30, 2008
Last Update Posted
: September 24, 2013
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Obstructive Sleep Apnea Syndrome | Drug: Atorvastatin treatment Other: CPAP device Other: sham CPAP treatment | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 54 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin |
Study Start Date : | May 2008 |
Actual Primary Completion Date : | February 2013 |
Actual Study Completion Date : | February 2013 |

Arm | Intervention/treatment |
---|---|
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
|
- 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. ]
- Evaluation of the inflammation occurring during OSAS. [ Time Frame: after 3 months of Atorvastatin or placebo treatment. ]
- Evaluation of the insulin-resistance associated to OSAS. [ Time Frame: after 3 months of Atorvastatin or placebo treatment. ]
- Evaluation of the hypercholesterolemia associated to OSAS. [ Time Frame: 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. [ Time Frame: after 6 months of treatments ]
- Measurement of the CPAP efficiency in comparison with sham CPAP in patients receiving the placebo. [ Time Frame: after 3 months of treatment. ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00669695
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 |
Principal Investigator: | Jean-Louis PEPIN, MD, PhD | University Hospital of Grenoble, France |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University Hospital, Grenoble |
ClinicalTrials.gov Identifier: | NCT00669695 History of Changes |
Other Study ID Numbers: |
0721 2007-005286-35 ( Registry Identifier: ID RCB ) |
First Posted: | April 30, 2008 Key Record Dates |
Last Update Posted: | September 24, 2013 |
Last Verified: | September 2013 |
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 |