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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-005286-35 | Registry Identifier | ID RCB |
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Interim analysis performed without efficient results
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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.
Secondary objectives of this clinical trial :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stat/CPAP | Placebo Comparator | Atorvastatin and CPAP treatments |
|
| Stat/sham CPAP | Placebo Comparator | Atorvastatin and sham CPAP treatments |
|
| Placebo/CPAP | Sham Comparator | Placebo and CPAP treatments |
|
| Placebo/sham CPAP | Active Comparator | Placebo and sham CPAP treatments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin treatment | Drug | Atorvastatin treatment: tablets of 40 mg Atorvastatin will be administered orally, respecting the dosage of 40 mg/day, for 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is the percent of peripheral arterial tone (PAT) improvement in comparison with the baseline situation. | after 3 months of Atorvastatin treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the inflammation occurring during OSAS. | after 3 months of Atorvastatin or placebo treatment. | |
| Evaluation of the insulin-resistance associated to OSAS. | after 3 months of Atorvastatin or placebo treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Louis PEPIN, MD, PhD | University Hospital of Grenoble, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitary Hospital of Angers | Angers | 49033 | France | |||
| Hospital of Annemasse |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16337480 | Background | 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. | |
| 26567858 | Derived | 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. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| ID | Term |
|---|---|
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
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|
| CPAP device | Other | 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 | Other | This device consists in a sham CPAP. It will be applied 3 months after the beginning of drug treatment and for 3 months. |
|
|
| Evaluation of the hypercholesterolemia associated to OSAS. | 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. | after 6 months of treatments |
| Measurement of the CPAP efficiency in comparison with sham CPAP in patients receiving the placebo. | after 3 months of treatment. |
| Annemasse |
| 74017 |
| France |
| University Hospital of Grenoble | Grenoble | 38043 | France |
| Universitary Hospital of Geneva | Geneva | 1211 | Switzerland |
| 25221387 | Derived | 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. |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |