Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-01-20 @ 4:44 AM
Study NCT ID:
NCT02578303
Status:
UNKNOWN
Last Update Posted:
2020-07-14
First Post:
2015-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Cerebral Arterial Vascular Flow and Sleep Apnea in Neurodegenerative Alterations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 139}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-13', 'studyFirstSubmitDate': '2015-10-09', 'studyFirstSubmitQcDate': '2015-10-15', 'lastUpdatePostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total arterial flowrate (measured by PC-MRI debit ml/Mn)', 'timeFrame': 'at day 1 after inclusion'}], 'secondaryOutcomes': [{'measure': 'sleep apnea measured by elderly polygraphy (Number of apneas / night)', 'timeFrame': 'at day 1 after inclusion up to 24 heures'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleep apnea', 'phase-contrast MRI', 'cerebral blood flow', 'vascular risk factor', 'dementia'], 'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': 'Obstructive sleep apnea syndrome (OSAS) is a sleep-disordered breathing characterized by the occurrence of repeated upper airway obstructions leading to airflow reduction (hypopnea) or cessation (apnea). The apnea-hypopnea index (AHI) is the number of apneas and hypopneas per hour of sleep. OSA patients often report cognitive complaints.\n\nAbout 25% of the elderly population is affected by this syndrome with a drastic increase of this rate among dementia patients. OSAS is considered to be an important risk factor for the development of hypertension, heart disease and stroke.', 'detailedDescription': 'Numerous studies pointed out the close relationship between sleep apnea and cognitive impairment. To the investigators\' knowledge, no trials have assessed the existence of a relationship between the IAH index and the cerebral arterial blood flow rate (macrocirculation). Developments in magnetic resonance imaging (MRI) provide new insights into the quantitative study of blood flow through phase contrast MRI also called "flow MRI". The main hypothesis tested in this study is the existence of a relationship between OSAS and total cerebral arterial vascular inflow measured by PC-MRI (in mL/min) in the elderly population.\n\n* Primary outcome: The apnea/hypopnea index (measured by nocturnal respiratory polygraphy) and total arterial flow rate (measured by PC-MRI)\n* Secondary outcomes:\n\n 1. Measurement of arrhythmia\n 2. Measurement of arterial blood pressure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '75 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Elderly patients about or over 75 years\n2. Any gender\n3. Dementia Group:\n\n 3.1. MMSE (Mini Mental State Examination)\\> 15\n\n 3.2. Diagnosis of dementia established according to DSM-IV\n\n 3.3. Dementia of the Alzheimer type from NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association)\n4. Control Group:\n\n Preserved cognitive function corresponding to a normal MMSE score by the standards of Poitrenaud\n5. Ability to understand and give consent freely (for demented subjects, a legal representative will be delegate)\n\nExclusion Criteria:\n\n1. Elderly patients under 75 years\n2. Anyone with a classic contraindication to MRI\n\n 2.1 Major behavioral disorders that do not allow the realization of MRI in optimal conditions\n\n 2.2 Claustrophobia\n\n 2.3 Presence of foreign non-compliant material\n\n 2.4 Presence of intraocular metal body\n3. Having a history of chest surgery or neurosurgical\n4. Chronic respiratory failure\n5. Suffering from dementia other than that associated with Alzheimer's disease\n6. Patients with a handicap\n7. Patients under legal protection"}, 'identificationModule': {'nctId': 'NCT02578303', 'acronym': 'VAAPS', 'briefTitle': 'Association Between Cerebral Arterial Vascular Flow and Sleep Apnea in Neurodegenerative Alterations', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Central Hospital Saint Quentin'}, 'officialTitle': 'Association Between Cerebral Arterial Vascular Flow and Sleep Apnea in Neurodegenerative Alterations', 'orgStudyIdInfo': {'id': 'RCB / N° 2014-A01617-40'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dementia group', 'description': 'Assessed by the insertion of an interaction parameter between cerebral blood flow and the group label(dementia or no-dementia).\n\nROC method will be used to find a threshold value of IAH that separates the two groups.\n\nInterventions:\n\n* Vascular flow measurement by PC-MRI\n* Neuropsychological assessment\n* Registration of sleep apnea\n* Registration of blood pressure\n* ECG holters\n* Blood test\n* Geriatric standard evaluation', 'interventionNames': ['Other: Vascular flow measurement by PC-MRI']}, {'type': 'OTHER', 'label': 'control group', 'description': 'Assessed by the insertion of an interaction parameter between cerebral blood flow and the group label(dementia or no-dementia).\n\nROC method will be used to find a threshold value of IAH that separates the two groups.\n\nInterventions:\n\n* Vascular flow measurement by PC-MRI\n* Neuropsychological assessment\n* Registration of sleep apnea\n* Registration of blood pressure\n* ECG holters\n* Blood test\n* Geriatric standard evaluation', 'interventionNames': ['Other: Vascular flow measurement by PC-MRI']}], 'interventions': [{'name': 'Vascular flow measurement by PC-MRI', 'type': 'OTHER', 'description': 'participants will undergo vascular flow measurement by PC-MRI at intra and extracranial levels', 'armGroupLabels': ['Dementia group', 'control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02100', 'city': 'Saint-Quentin', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'ATTIER-ZMUDKA Jadwiga, PH', 'role': 'CONTACT', 'email': 'j.attier@ch-stquentin.fr', 'phone': '0323067861'}, {'name': 'BOULANOUAR Abdelkrim, CRA', 'role': 'CONTACT', 'email': 'A.BOULANOUAR@ch-stquentin.fr', 'phone': '0323067861'}, {'name': 'ATTIER-ZMUDKA MS Jadwiga, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'DOUADI M Youcef, ph', 'role': 'SUB_INVESTIGATOR'}, {'name': 'SOREL ms Claire, ph', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CH Saint-Quentin', 'geoPoint': {'lat': 49.84889, 'lon': 3.28757}}], 'centralContacts': [{'name': 'ATTIER Jadwiga, MD', 'role': 'CONTACT', 'email': 'j.attier@ch-stquentin.fr', 'phone': '0033323067216'}, {'name': 'BOULANOPUAR Abdelkrim, CRA', 'role': 'CONTACT', 'email': 'a.boulanouar@ch-stquentin.fr', 'phone': '0033323067861'}], 'overallOfficials': [{'name': 'ATTIER Jadwiga, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH SAINT-QUENTIN'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital Saint Quentin', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}