Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT05491967
Status:
COMPLETED
Last Update Posted:
2025-09-08
First Post:
2022-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Vascular Risk in Patients Treated for Obstructive Sleep Apnea/Hypopnea 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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2022-07-08', 'studyFirstSubmitQcDate': '2022-08-05', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'morbimortality vascular criteria', 'timeFrame': 'up to 6 months', 'description': 'Presence or absence of cardiovascular event'}, {'measure': 'morbimortality vascular criteria', 'timeFrame': 'up to 6 months', 'description': 'Presence or absence of neurologic event'}, {'measure': 'morbimortality vascular criteria', 'timeFrame': 'up to 6 months', 'description': 'Presence or absence of ophthalmologic event'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiovascular risk'], 'conditions': ['Obstructive Sleep Apnea/Hypopnea Syndrome']}, 'descriptionModule': {'briefSummary': 'a monocentric,non interventional, prospective study to compare cardiovascular risk in patients with Obstructive Sleep Apnea/Hypopnea Syndrome treated with Continuous Positive Airway Pressure (CPAP) and Mandibular Advancement Orthosis.', 'detailedDescription': 'The first-line treatment of severe Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS) is nocturnal ventilation with Continuous Positive Airway Pressure (CPAP). and The second-line treatment is the mandibular advancement orthosis (MAO)\\].\n\nCPAP is the most effective treatment to reduce the apnea-hypopnea index (AHI). However, its tolerance is sometimes difficult, causing many discontinuations.\n\nThe purpose of this review is to evaluate a vascular morbimortality criteria:\n\n* Cardiovascular: myocardial infarction, heart failure, rhythm disorder\n* Neurological: transient or non transient stroke\n* ophthalmologic: anterior ischemic optic neuropathy, occlusion of the central artery or central retinal vein occlusion'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Obstructive Sleep Apnea/Hypopnea Syndrome treated with With Continuous Positive Airway Pressure (CPAP) or Mandibular Advancement Orthosis', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obstructive Sleep Apnea/Hypopnea Syndrome treated with With Continuous Positive Airway Pressure (CPAP) or Mandibular Advancement Orthosis\n* Age ≥ 18 years old\n* Read, write and understand the French language\n\nExclusion Criteria:\n\n* Patient under guardianship, deprived of liberty, safeguard of justice\n* Refusal to participate in research'}, 'identificationModule': {'nctId': 'NCT05491967', 'acronym': 'SAHOSVAS', 'briefTitle': 'Comparison of Vascular Risk in Patients Treated for Obstructive Sleep Apnea/Hypopnea Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de Valence'}, 'officialTitle': 'Comparison of Vascular Risk in Patients Treated for Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS) With Continuous Positive Airway Pressure (CPAP) and Mandibular Advancement Orthosis', 'orgStudyIdInfo': {'id': 'RIPH-CHV-07'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Continuous Positive Airway Pressure (CPAP)', 'description': 'Obstructive Sleep Apnea/Hypopnea Syndrome treated with Continuous Positive Airway Pressure (CPAP'}, {'label': 'Mandibular Advancement Orthosis', 'description': 'Obstructive Sleep Apnea/Hypopnea Syndrome treated with Mandibular Advancement Orthosis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '26953', 'city': 'Valence', 'state': 'Drome', 'country': 'France', 'facility': 'Ch Valence', 'geoPoint': {'lat': 44.9256, 'lon': 4.90956}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de Valence', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}