Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT00764218
Status:
UNKNOWN
Last Update Posted:
2008-10-01
First Post:
2008-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiovascular Phenotype Study in Patients With Obstructive Sleep Apnea Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D006973', 'term': 'Hypertension'}], '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'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2001-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2001-01', 'completionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-09-30', 'studyFirstSubmitDate': '2008-09-30', 'studyFirstSubmitQcDate': '2008-09-30', 'lastUpdatePostDateStruct': {'date': '2008-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cardiovascular phenotype study in patients with non treated obstructive sleep apnea syndrome', 'timeFrame': '6 years'}], 'secondaryOutcomes': [{'measure': 'characterization of arterial blood pressure, sympathetic activity, functional and morphological cardiovascular modifications. Effect of a treatment of obstructive sleep apnea syndrome on those different parameters.', 'timeFrame': '6 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obstructive sleep apnea syndrome', 'Hypertension', 'Cardiovascular phenotype'], 'conditions': ['Obstructive Sleep Apnea Syndrome', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '9367465', 'type': 'BACKGROUND', 'citation': 'Pankow W, Nabe B, Lies A, Becker H, Kohler U, Kohl FV, Lohmann FW. Influence of sleep apnea on 24-hour blood pressure. Chest. 1997 Nov 5;112(5):1253-8. doi: 10.1378/chest.112.5.1253.'}, {'pmid': '9383171', 'type': 'BACKGROUND', 'citation': 'Portaluppi F, Provini F, Cortelli P, Plazzi G, Bertozzi N, Manfredini R, Fersini C, Lugaresi E. Undiagnosed sleep-disordered breathing among male nondippers with essential hypertension. J Hypertens. 1997 Nov;15(11):1227-33. doi: 10.1097/00004872-199715110-00006.'}, {'pmid': '1328361', 'type': 'BACKGROUND', 'citation': 'Calver A, Collier J, Moncada S, Vallance P. Effect of local intra-arterial NG-monomethyl-L-arginine in patients with hypertension: the nitric oxide dilator mechanism appears abnormal. J Hypertens. 1992 Sep;10(9):1025-31.'}, {'pmid': '7846459', 'type': 'BACKGROUND', 'citation': 'Strohl KP, Novak RD, Singer W, Cahan C, Boehm KD, Denko CW, Hoffstem VS. Insulin levels, blood pressure and sleep apnea. Sleep. 1994 Oct;17(7):614-8. doi: 10.1093/sleep/17.7.614.'}, {'pmid': '1730456', 'type': 'BACKGROUND', 'citation': 'Landsberg L. Hyperinsulinemia: possible role in obesity-induced hypertension. Hypertension. 1992 Jan;19(1 Suppl):I61-6. doi: 10.1161/01.hyp.19.1_suppl.i61.'}, {'pmid': '8912770', 'type': 'BACKGROUND', 'citation': 'Carlson JT, Hedner JA, Sellgren J, Elam M, Wallin BG. Depressed baroreflex sensitivity in patients with obstructive sleep apnea. Am J Respir Crit Care Med. 1996 Nov;154(5):1490-6. doi: 10.1164/ajrccm.154.5.8912770.'}, {'pmid': '10805822', 'type': 'BACKGROUND', 'citation': 'Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000 May 11;342(19):1378-84. doi: 10.1056/NEJM200005113421901.'}, {'pmid': '10770144', 'type': 'BACKGROUND', 'citation': "Nieto FJ, Young TB, Lind BK, Shahar E, Samet JM, Redline S, D'Agostino RB, Newman AB, Lebowitz MD, Pickering TG. Association of sleep-disordered breathing, sleep apnea, and hypertension in a large community-based study. Sleep Heart Health Study. JAMA. 2000 Apr 12;283(14):1829-36. doi: 10.1001/jama.283.14.1829."}, {'pmid': '10673727', 'type': 'BACKGROUND', 'citation': "Baguet JP, Mallion JM, Moreau-Gaudry A, Noirclerc M, Peoc'h M, Siche JP. Relationships between cardiovascular remodelling and the pulse pressure in never treated hypertension. J Hum Hypertens. 2000 Jan;14(1):23-30. doi: 10.1038/sj.jhh.1000933."}, {'pmid': '20562120', 'type': 'DERIVED', 'citation': 'Baguet JP, Barone-Rochette G, Levy P, Vautrin E, Pierre H, Ormezzano O, Pepin JL. Left ventricular diastolic dysfunction is linked to severity of obstructive sleep apnoea. Eur Respir J. 2010 Dec;36(6):1323-9. doi: 10.1183/09031936.00165709. Epub 2010 Jun 18.'}, {'pmid': '20057899', 'type': 'DERIVED', 'citation': 'Baguet JP, Nadra M, Barone-Rochette G, Ormezzano O, Pierre H, Pepin JL. Early cardiovascular abnormalities in newly diagnosed obstructive sleep apnea. Vasc Health Risk Manag. 2009;5:1063-73. doi: 10.2147/vhrm.s8300. Epub 2009 Dec 29.'}]}, 'descriptionModule': {'briefSummary': 'Patients with obstructive sleep apnea syndrome have permanent variations of their hemodynamic parameters during the night : heart rate, arterial blood pressure, cardiac output. This is due to the repetition of respiratory events (obstructive apnea and hypopnea) leading to frequent micro-arousals. These disorders have several consequences : hypertension, NO-dependent vasodilatation impairment, baroreceptor reflex impairment, insulin resistance and other cardiovascular impairments.', 'detailedDescription': 'Objective of the study is to characterize the cardiovascular phenotype of patients with obstructive sleep apnea syndrome, relative to the presence of hypertension or not. Hypertension should not have been previously treated. 2 groups of apneic patients (SAS+HTA+ and SAS+HTA-) will be compared together, referred to group of non apneic but hypertensive patients (SAS-HTA+) and non apneic / non hypertensive patients (SAS-HTA-).\n\nApneic and hypertensive patients may have a sympathetic nervous system activation and a much more important vascular and baroreceptor reflex impairment, than non apneic but hypertensive patients.\n\nDuring the study, a second visit as control will be done for apneic patients only, 3 to 6 months after SAS treatment setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients with or without obstructive sleep apnea syndrome (AHI \\> 15)\n* patients with or without hypertension\n\nExclusion Criteria:\n\n* known or expected secondary hypertension\n* pathologies with consequences on arterial blood pressure regulation: Parkinson's disease, patients with renal or cardiac graft, severe heart failure\n* drugs with consequences on arterial blood pressure regulation : vasoconstrictors, vasodilatators, béta-agonists, antagonists, nitrites, theophylline, dipyridamol, sildenafil, immunosuppressors, IMAO, neuroleptics, tricyclic antidepressants, corticoids or long-term oral (\\>10 days) non steroidal anti-inflammatory drugs, oestroprogestative treatments\n* atrial fibrillation, frequent extrasystoles (\\> or = to 10/minute)\n* bedridden patients\n* night shift workers\n* surgical or carotid stenting history\n* subjects unwilling or unable to provide written, signed and dated informed consent\n* patient previously treated for obstructive sleep apnea syndrome (positive airway pressure, forward mandible prosthesis, maxillofacial surgery"}, 'identificationModule': {'nctId': 'NCT00764218', 'acronym': 'SAS-HTA', 'briefTitle': 'Cardiovascular Phenotype Study in Patients With Obstructive Sleep Apnea Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Cardiovascular Phenotype Study in Patients With Obstructive Sleep Apnea Syndrome : Role of Hypertension', 'orgStudyIdInfo': {'id': 'DGS2001/0398'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SAS+HTA+', 'description': 'Obstructive sleep apnea syndrome and hypertension', 'interventionNames': ['Device: Positive airway pressure treatment']}, {'type': 'EXPERIMENTAL', 'label': 'SAS+HTA-', 'description': 'non hypertensive patients with obstructive sleep apnea syndrome', 'interventionNames': ['Device: Positive airway pressure treatment']}, {'type': 'EXPERIMENTAL', 'label': 'SAS-HTA+', 'description': 'hypertensive patients without obstructive sleep apnea syndrome', 'interventionNames': ['Other: No positive airway pressure treatment']}, {'type': 'EXPERIMENTAL', 'label': 'SAS-HTA-', 'description': 'non hypertensive patients without obstructive sleep apnea syndrome', 'interventionNames': ['Other: No positive airway pressure treatment']}], 'interventions': [{'name': 'Positive airway pressure treatment', 'type': 'DEVICE', 'otherNames': ['CPAP treatment'], 'description': 'Positive airway pressure treatment as long as necessary', 'armGroupLabels': ['SAS+HTA+', 'SAS+HTA-']}, {'name': 'No positive airway pressure treatment', 'type': 'OTHER', 'otherNames': ['No CPAP treatment'], 'description': 'No treatment', 'armGroupLabels': ['SAS-HTA+', 'SAS-HTA-']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Grenoble', 'state': 'Isère', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Philippe JB BAGUET, PhD', 'role': 'CONTACT', 'email': 'JBaguet@chu-grenoble.fr', 'phone': '0033476764226', 'phoneExt': '64226'}, {'name': 'Jean-Louis JP PEPIN, PhD', 'role': 'CONTACT', 'email': 'JPepin@chu-grenoble.fr', 'phone': '0033476768473', 'phoneExt': '68473'}], 'facility': 'Cardiology and hypertension service', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'centralContacts': [{'name': 'Jean-Philippe JB BAGUET, PhD', 'role': 'CONTACT', 'email': 'JBaguet@chu-grenoble.fr', 'phone': '00330476764226', 'phoneExt': '64226'}, {'name': 'Jean-Louis JP PEPIN, PhD', 'role': 'CONTACT', 'email': 'JPepin@chu-grenoble.fr', 'phone': '00330476768473', 'phoneExt': '68473'}], 'overallOfficials': [{'name': 'Jean-Philippe JB BAGUET, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'BAGUET Jean-Philippe, PhD', 'oldOrganization': 'University Hospital Grenoble'}}}}