Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-02-21 @ 6:31 PM
Study NCT ID:
NCT03373357
Status:
UNKNOWN
Last Update Posted:
2017-12-14
First Post:
2017-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypertension and Cardiovascular Risk Associated With Obstructive Sleep Apnea in Adult in Guadeloupe (French West Indies)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "All the patients will have sampling blood specific to the protocol:\n\n* Insulinémie\n* US CRP(TEACHERS' CENTRE)\n* Implementation of a sérothèque"}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2019-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-08', 'studyFirstSubmitDate': '2017-12-04', 'studyFirstSubmitQcDate': '2017-12-08', 'lastUpdatePostDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-11-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the frequency of hypertension', 'timeFrame': 'At the of the enrollment period, an average of 3 years", etc.).', 'description': 'The primary outcome measure the frequency of hypertension and non-dipper pattern evaluated by 48-hour ambulatory blood pressure monitoring in an adult population identified obstructive sleep apnea/non-obstructive sleep apnea during overnight polygraphy.'}], 'secondaryOutcomes': [{'measure': 'The cardio-metabolic factors', 'timeFrame': '"through study completion, an average of 8 years"', 'description': 'All the enrolled patients will be followed during 5 years and particularly concerning:\n\n* the appearance of new risk cardiovascular factors\n* the advent of cardiovascular events'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleep apnea', 'arterial hypertension', 'cardiovascular risk'], 'conditions': ['Hypertension Arterial']}, 'descriptionModule': {'briefSummary': 'The MAPA is the reference method to estimate the PA during the SAHOS. The MAPA can be recommended over 48 hours: indeed, the PA falls at the beginning of every apnea then increases gradually up to a pressif peak arising at the time of the ventilatoire resumption. These variations arise under the influence of 4 stimulus: the désaturation in O2, the rise of the PaCO2, the increase of the respiratory effort and the microawakening of the end of apnea who are at the origin of a sympathetic stimulation.\n\nConsequently a better diagnostic approach of the HTA (confirmation of a resistant HTA, an identification of the masked HTA and the patients " not dipper " by the MAPA), the identification of the SAHOS, and a better coverage) of the associated cardiovascular risk factors are essential and establish a stake in public health.\n\nTo investigator\'s knowledge, no datum or study on the association HTA-SAHOS and its consequences was until then realized in the French overseas departments.', 'detailedDescription': 'In Guadeloupe, data on the relationships between arterial hypertension and obstructive sleep apnea are unavailable. The aim of this study was: to assess the frequency of hypertension and non-dipper pattern evaluated by 48-hour ambulatory blood pressure monitoring in an adult population identified obstructive sleep apnea/non-obstructive sleep apnea during overnight polygraphy ; to determine the cardio-metabolic factors associated with obstructive sleep apnea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient suspected of SAHOS;\n* Patient or third-party responsible for receiving information on the study and who signed informed consent ;\n* Patient age over 18 years; Patient living in Guadeloupe.\n\nExclusion Criteria:\n\n* Patient non-affiliated to the social security scheme ;\n* Patient with obstructive bronchopneumopathy, neuro-muscular pathology,\n* central and mixed SAS, cardiac arrhythmia,\n* systemic and chronic inflammatory syndrome ; -\n* Pregnant and lactating patient ;\n* patient in emergency.'}, 'identificationModule': {'nctId': 'NCT03373357', 'acronym': 'HTA-SAHOS', 'briefTitle': 'Hypertension and Cardiovascular Risk Associated With Obstructive Sleep Apnea in Adult in Guadeloupe (French West Indies)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de la Guadeloupe'}, 'officialTitle': 'Hypertension and Cardiovascular Risk Associated With Obstructive Sleep Apnea in Adult in Guadeloupe (French West Indies)', 'orgStudyIdInfo': {'id': 'RBM-PAP- 2007/19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patient not SAHOS', 'description': 'The medical follow-up of patients no SAHOS will be assured by the investigators of the unity of cardiovascular explorations: phone consultation in 1 month, 3mois, then every 6 months, and an annual visit.', 'interventionNames': ['Other: Patient not SAHOS']}, {'type': 'OTHER', 'label': 'Patient SAHOS sailed by the ventilation in PPC and not sailed', 'description': 'The patients who have a SAHOS sailed by the ventilation in PPC will be estimated and followed in 3 months then every 6 months by the investigators of the service of pneumology and the unity of cardiovascular explorations. The control of the material and its tolerance, the data supplied by the service providers (bodies of ventilation at home) will be estimated by the investigator of the service of pneumology. IDE the unity of cardiovascular explorations will plan and will realize a 2nd one MAPA after 3 months of ventilation in PPC.', 'interventionNames': ['Other: Patient SAHOS sailed by the ventilation in PPC and not sailed']}], 'interventions': [{'name': 'Patient not SAHOS', 'type': 'OTHER', 'description': 'Phone consultation in 1 month, 3mois, then every 6 months, and an annual visit.\n\n* Cardiovascular events arisen during the duration of the study\n* Modifications of the lifestyle: alcohol, physical activity\n* Weight\n* Clinical measure of the PA\n* Clinical examination\n* The collection of the cardiovascular events arisen during the duration of the study will be realized for all the inclusive patients', 'armGroupLabels': ['Patient not SAHOS']}, {'name': 'Patient SAHOS sailed by the ventilation in PPC and not sailed', 'type': 'OTHER', 'description': 'Questionnaire of subjective evaluation of diurnal slumber: scale of Epworth and search for appearance of at least 2 of the following symptoms: sleep not salvage dealer, night-breathlessnesses, multiple awakenings, fatigue, disordersconfusions, nycturie, snore.\n\n* Questionnaire of evaluation of the global quality of life of the SAHOS\n* Appearance of new cardiovascular risk factors\n* Cardiovascular events arisen during the duration of the study\n* Modification of the current treatments\n* Modifications of the lifestyle: alcohol, physical activity\n* Weight\n* Clinical measure of the PA\n* Clinical examination\n* The collection of the cardiovascular events arisen during the duration of the study will be realized for all the inclusive patients', 'armGroupLabels': ['Patient SAHOS sailed by the ventilation in PPC and not sailed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97159', 'city': 'Pointe-à-Pitre', 'country': 'Guadeloupe', 'facility': 'Hospital University Center of Pointe-à-Pitre', 'geoPoint': {'lat': 16.23638, 'lon': -61.53459}}], 'overallOfficials': [{'name': 'Rachel BILLY BRISSAC, Dorctor cardiovascular', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital University Center of Pointe-à-Pitre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de la Guadeloupe', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}