Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-02-20 @ 5:56 PM
Study NCT ID:
NCT01089257
Status:
TERMINATED
Last Update Posted:
2023-01-05
First Post:
2010-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Impairments and Obstructive Sleep Apnea Syndrome
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}}, 'statusModule': {'whyStopped': 'Delayed inclusion at more than 14 years from the start of the study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2021-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-03', 'studyFirstSubmitDate': '2010-03-16', 'studyFirstSubmitQcDate': '2010-03-16', 'lastUpdatePostDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiovascular risks', 'Oxidative stress', 'Systemic inflammation', 'Endothelial function', 'Peripheral Arterial Tone', 'Positive Airway Pressure'], 'conditions': ['Subclinical Cardiovascular Impairments', 'Obstructive Sleep Apnea Syndrome']}, 'referencesModule': {'references': [{'pmid': '12742277', 'type': 'BACKGROUND', 'citation': 'Lattimore JD, Celermajer DS, Wilcox I. Obstructive sleep apnea and cardiovascular disease. J Am Coll Cardiol. 2003 May 7;41(9):1429-37. doi: 10.1016/s0735-1097(03)00184-0.'}, {'pmid': '15301332', 'type': 'BACKGROUND', 'citation': 'Parish JM, Somers VK. Obstructive sleep apnea and cardiovascular disease. Mayo Clin Proc. 2004 Aug;79(8):1036-46. doi: 10.4065/79.8.1036.'}, {'pmid': '14532320', 'type': 'BACKGROUND', 'citation': 'Shamsuzzaman AS, Gersh BJ, Somers VK. Obstructive sleep apnea: implications for cardiac and vascular disease. JAMA. 2003 Oct 8;290(14):1906-14. doi: 10.1001/jama.290.14.1906.'}, {'pmid': '15781100', 'type': 'BACKGROUND', 'citation': 'Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7.'}, {'pmid': '15901608', 'type': 'BACKGROUND', 'citation': 'Drager LF, Bortolotto LA, Lorenzi MC, Figueiredo AC, Krieger EM, Lorenzi-Filho G. Early signs of atherosclerosis in obstructive sleep apnea. Am J Respir Crit Care Med. 2005 Sep 1;172(5):613-8. doi: 10.1164/rccm.200503-340OC. Epub 2005 May 18.'}, {'pmid': '22761257', 'type': 'DERIVED', 'citation': 'Stanke-Labesque F, Pepin JL, de Jouvencel T, Arnaud C, Baguet JP, Petri MH, Tamisier R, Jourdil JF, Levy P, Back M. Leukotriene B4 pathway activation and atherosclerosis in obstructive sleep apnea. J Lipid Res. 2012 Sep;53(9):1944-51. doi: 10.1194/jlr.P022814. Epub 2012 Jul 3.'}]}, 'descriptionModule': {'briefSummary': 'Which are the anthropometric parameters and/or of severity of the syndrome of apnea of sleep (SAS) which make it possible to anticipate occurred of vascular anomalies, anatomical and/or functional precociously found among patients SAS? Secondary objectives:\n\n1. Which are the anthropometric parameters and/or of severity of SAS allowing to anticipate occurred of early of the cardiac function and/or rhythmic anomalies found among patients SAS?\n2. Do there exist biological markers who allow to anticipate the early vascular lesions or the anomalies beginners of the cardiac function?\n3. Which are the cardiovascular effects of a treatment of SAS by Continuous Positive Pressure (PC) after 3 to 6 months of treatment?\n4. Do the identified early cardiovascular attacks and/or the biological anomalies make it possible to predict occurred of cardiovascular events in this population of patients carrying SAS (followed longitudinal at 5 years)?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '78 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with obstructive sleep apnea syndrome (Apnea/Hypopnea index \\> 15)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female from 18 to 78 years old\n* Patients with obstructive sleep apnea syndrome (Apnea/Hypopnea index \\> 15)\n* ambulatory patients\n* patients who have signed the inform consent form\n* patients with health insurance\n\nExclusion Criteria:\n\n* Body Mass Index upper or equal to 30\n* cardiovascular pathology except blood pressure hypertension\n* known or treated diabetes\n* pathologies with consequence on blood pressure regulation\n* drugs intakes with consequence on blood pressure regulation\n* patient with chronic obstructive pulmonary disease\n* atrial fibrillation or more than 10/minute extrasystoles\n* bedridden patients or patients with decreased mobility\n* patients working at night or with shift work\n* patients with carotid stenting or surgery history\n* patients unable to sign the inform consent form\n* patients already treated by cPAP or dental appliance for OSAS in the last 6 months\n* pregnant or suckling female\n* patients under supervision or trusteeship\n* patients taking part in another clinical trial'}, 'identificationModule': {'nctId': 'NCT01089257', 'acronym': 'INFRASAS', 'briefTitle': 'Cardiovascular Impairments and Obstructive Sleep Apnea Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Subclinical Cardiovascular Impairments in Patients With Obstructive Sleep Apnea Syndrome', 'orgStudyIdInfo': {'id': '06PHR03'}}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': "France : Laboratoire d'explorations fonctionnelles du système nerveux - Functional explorations laboratory of nervous system", 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'France : Laboratoire EFCR - Functional cardiorespiratory explorations laboratory', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '42000', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'France : Laboratoire EFCR - Functional cardiorespiratory explorations laboratory', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Jean-Louis JP PEPIN, ProfessorPhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, {'name': 'Hôpital de la Croix-Rousse', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}