Ignite Creation Date:
2025-12-24 @ 1:15 PM
Ignite Modification Date:
2026-04-13 @ 12:09 AM
Study NCT ID:
NCT00669695
Status:
TERMINATED
Last Update Posted:
2013-09-24
First Post:
2008-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'}], 'ancestors': [{'id': 'D000924', 'term': 'Anticholesteremic Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'whyStopped': 'Interim analysis performed without efficient results', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-23', 'studyFirstSubmitDate': '2008-04-21', 'studyFirstSubmitQcDate': '2008-04-28', 'lastUpdatePostDateStruct': {'date': '2013-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint is the percent of peripheral arterial tone (PAT) improvement in comparison with the baseline situation.', 'timeFrame': 'after 3 months of Atorvastatin treatment.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the inflammation occurring during OSAS.', 'timeFrame': 'after 3 months of Atorvastatin or placebo treatment.'}, {'measure': 'Evaluation of the insulin-resistance associated to OSAS.', 'timeFrame': 'after 3 months of Atorvastatin or placebo treatment.'}, {'measure': 'Evaluation of the hypercholesterolemia associated to OSAS.', 'timeFrame': 'after 3 months of Atorvastatin or placebo treatment.'}, {'measure': '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.', 'timeFrame': 'after 6 months of treatments'}, {'measure': 'Measurement of the CPAP efficiency in comparison with sham CPAP in patients receiving the placebo.', 'timeFrame': 'after 3 months of treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['statins', 'cardiovascular risk', 'Obstructive sleep apnea syndrome (OSAS) patients'], 'conditions': ['Obstructive Sleep Apnea Syndrome']}, 'referencesModule': {'references': [{'pmid': '16337480', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26567858', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '25221387', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nAn interim analysis will be performed when 25 patients per group will be included.', 'detailedDescription': 'Secondary objectives of this clinical trial :\n\n* To evaluate the effect of Atorvastatin in comparison with the placebo on the inflammation occurring during OSAS, after 3 months of treatment.\n* To evaluate the effect of Atorvastatin in comparison with the placebo on the insulin-resistance associated to OSAS, after 3 months of treatment.\n* To evaluate the effect of Atorvastatin in comparison with the placebo on the hypercholesterolemia associated to OSAS, after 3 months of treatment.\n* 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.\n* To measure the CPAP efficiency in comparison with sham CPAP in patients receiving the placebo, after 3 months of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women \\> 18 years old\n* Subjects diagnosed with OSAS (apnea/hypopnea index = AHI \\> 30/h)\n* Subjects with clinical ATH from grade I or II controlled with mono-therapy(140\\<SAP\\<180 mmHg and 90\\<DAP\\<110 mmHg)\n\nExclusion Criteria:\n\n* Patients with a history of prior stroke or coronary ischemic disease\n* Chronic respiratory disease (PaO2 \\< 60 mmHg and/or PaCO2 \\> 45 mmHg)\n* Lung disease\n* Hypothyroidism\n* Statin treatment\n* Antihypertensive treatment with more than one drug\n* Pregnant or lactating women\n* Alcohol consumption \\> 3 units/day\n* Treatment by itraconazole, ketoconazole, antiprotease, fibrates, antivitamin K, diltiazem, verapamil, erythromycin, clarithromycin, cyclosporin.\n* Hypersensitivity to one of the drug compounds\n* Patients with modified concomitant treatments during the 3 months before inclusion\n* Potentially dangerous sleepiness\n* Jobs at risk'}, 'identificationModule': {'nctId': 'NCT00669695', 'acronym': 'StatinflaSAS', 'briefTitle': 'Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin', 'orgStudyIdInfo': {'id': '0721'}, 'secondaryIdInfos': [{'id': '2007-005286-35', 'type': 'REGISTRY', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Stat/CPAP', 'description': 'Atorvastatin and CPAP treatments', 'interventionNames': ['Drug: Atorvastatin treatment', 'Other: CPAP device']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Stat/sham CPAP', 'description': 'Atorvastatin and sham CPAP treatments', 'interventionNames': ['Drug: Atorvastatin treatment', 'Other: sham CPAP treatment']}, {'type': 'SHAM_COMPARATOR', 'label': 'Placebo/CPAP', 'description': 'Placebo and CPAP treatments', 'interventionNames': ['Other: CPAP device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo/sham CPAP', 'description': 'Placebo and sham CPAP treatments', 'interventionNames': ['Other: sham CPAP treatment']}], 'interventions': [{'name': 'Atorvastatin treatment', 'type': 'DRUG', 'otherNames': ['statin'], 'description': 'Atorvastatin treatment: tablets of 40 mg Atorvastatin will be administered orally, respecting the dosage of 40 mg/day, for 6 months.', 'armGroupLabels': ['Stat/CPAP', 'Stat/sham CPAP']}, {'name': 'CPAP device', 'type': 'OTHER', 'otherNames': ['positive air way pressure'], 'description': '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.', 'armGroupLabels': ['Placebo/CPAP', 'Stat/CPAP']}, {'name': 'sham CPAP treatment', 'type': 'OTHER', 'otherNames': ['sham CPAP'], 'description': 'This device consists in a sham CPAP. It will be applied 3 months after the beginning of drug treatment and for 3 months.', 'armGroupLabels': ['Placebo/sham CPAP', 'Stat/sham CPAP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49033', 'city': 'Angers', 'country': 'France', 'facility': 'Universitary Hospital of Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '74017', 'city': 'Annemasse', 'country': 'France', 'facility': 'Hospital of Annemasse', 'geoPoint': {'lat': 46.19439, 'lon': 6.23775}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'University Hospital of Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '1211', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Universitary Hospital of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Jean-Louis PEPIN, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Grenoble, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}