Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-29 @ 10:12 PM
Study NCT ID:
NCT01135303
Status:
COMPLETED
Last Update Posted:
2011-07-21
First Post:
2010-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of VistaO2 Device in Screening of Sleep Apnea/Hypopnea Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 182}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-20', 'studyFirstSubmitDate': '2010-05-25', 'studyFirstSubmitQcDate': '2010-05-31', 'lastUpdatePostDateStruct': {'date': '2011-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep apnea hypopnea syndrome', 'timeFrame': 'Day 1', 'description': 'Apnea hypopnea index higher than 15, evaluated by polysomnography.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sleep Apnea Syndromes', 'Polysomnography', 'Holter ECG', 'Thoracic impedance', 'Heart rate variability'], 'conditions': ['Sleep Apnea Syndromes']}, 'referencesModule': {'references': [{'pmid': '22805548', 'type': 'DERIVED', 'citation': 'Chouchou F, Poupard L, Philippe C, Court-Fortune I, Barthelemy JC, Roche F. Thoracic impedance, in association with oximetry, in a multi-modal ECG Holter system is useful for screening sleep disordered breathing. Int J Cardiol. 2013 Feb 10;163(1):100-2. doi: 10.1016/j.ijcard.2012.06.082. Epub 2012 Jul 16. No abstract available.'}]}, 'descriptionModule': {'briefSummary': "The high prevalence (9% in men and 4% in women) of sleep apnea / hypopnea syndrome (SAHS) in adults is now well documented as well as its cardiovascular repercussions. Previous studies showed a conclusive link between SAHS and severe cardiovascular diseases such as hypertension, myocardial infarction, heart failure and stroke.Then, SAHS is a public health issue in adults.\n\nIn this context, early detection of such a disease is crucial if the management is tailored to the patient, the practitioner's choice of therapy moving towards continuous positive airway pressure (CPAP) or mandibular advancement device. The detection is based on full nocturnal polysomnography or polygraphic recordings. Polysomnography remains the gold standard but it is a time consuming and costly examination. Polygraphic recording is a test that allows simplified the diagnosis of severe patients, but may not be sufficient for mild form of SAHS. Thus, the SAHS is a pathology under-diagnosed and under-treated. The validation of a technique for identifying patients most at risk to either limit the number of polysomnographic examination is requested.", 'detailedDescription': 'In this perspective, the development of a product screening sleep related breathing disorders for physicians, cardiologists, internists (not specialized sleep experts) would fill this need. It allows for a reliable first screening for their patients in parallel with a routine cardiological examination. Imposing a minimal human and material, the ECG Holter recorder "VistaO2" (NOVACOR, Rueil-Malmaison, France) is a device designed to meet these requirements. This device fits into the daily management of patients with cardiac arrhythmias or sinus/atrioventricular conduction disorders, and of patients suffering myocardial infarction (arrhythmic risk stratification, detection of silent myocardial ischemia).\n\nAnalysis of heart rate variability (HRV) has already shown interest in screening SAHS. We therefore wish to evaluate the performance of the analysis of data from the screening tool VistaO2 face what the gold standard synchronized polysomnography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* sleep apnea hypopnea syndrome suspicion\n* written consent\n\nExclusion Criteria:\n\n* pacemaker\n* diabetes\n* atrial fibrillation\n* electrode allergy'}, 'identificationModule': {'nctId': 'NCT01135303', 'acronym': 'VISTAO2', 'briefTitle': 'Effectiveness of VistaO2 Device in Screening of Sleep Apnea/Hypopnea Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Effectiveness of VistaO2 Device in Screening of Sleep Apnea/Hypopnea Syndrome', 'orgStudyIdInfo': {'id': '0808119'}, 'secondaryIdInfos': [{'id': '2008-A01530-55', 'type': 'OTHER', 'domain': 'AFSSAPS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VistaO2 device', 'description': 'This device combines the transcutaneous oxyhemoglobin saturation (allowing to compute the oxyhemoglobin desaturation index), the slow variations in heart rate and an index of nocturnal respiratory events calculated by analyzing the movements of the chest performed by chest impedance variations.', 'interventionNames': ['Device: VistaO2 device']}], 'interventions': [{'name': 'VistaO2 device', 'type': 'DEVICE', 'otherNames': ['VistaO2 : ECG Holter recorder (Novacor, Rueil-Malmaison, France).'], 'description': 'Full night VistaO2 device monitoring synchronized with the gold standard polysomnography.', 'armGroupLabels': ['VistaO2 device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75000', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital TENON - APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU de Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Frédéric ROCHE, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Saint-Etienne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novacor', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Clément CAILLAUX', 'oldOrganization': 'Centre Hospitalier Universitaire de Saint-Etienne'}}}}