Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-02-22 @ 7:01 AM
Study NCT ID:
NCT04011358
Status:
WITHDRAWN
Last Update Posted:
2021-10-27
First Post:
2019-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012170', 'term': 'Retinal Vein Occlusion'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'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': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'case-control comparison study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Given the health context and the work overload, this study will not be possible. We therefore abandon this project', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-20', 'studyFirstSubmitDate': '2019-06-07', 'studyFirstSubmitQcDate': '2019-07-04', 'lastUpdatePostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apnea Hypopnea index >5/hour', 'timeFrame': 'Hour 12', 'description': 'Obstructive Sleepin Apnea diagnostic depends only on the AHI which is measured by the Sleeping Monitor at home.'}], 'secondaryOutcomes': [{'measure': 'Berlin Questionnaire sleep test', 'timeFrame': 'Hour 12', 'description': 'High Risk of Sleep Apnea Syndrome:\n\nIf there are 2 or more Categories where the score is 2 or above\n\nLow Risk of Sleep Apnea Syndrome:\n\nIf there is only 1 or no Categories where the score is 2 or above'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Retinal Vein Occlusion', 'central retinal vein occlusion', 'branch retinal vein occlusion', 'obstructive sleep apnea', 'sleep apnea'], 'conditions': ['Retinal Vein Occlusion', 'Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '21149775', 'type': 'RESULT', 'citation': 'Glacet-Bernard A, Leroux les Jardins G, Lasry S, Coscas G, Soubrane G, Souied E, Housset B. Obstructive sleep apnea among patients with retinal vein occlusion. Arch Ophthalmol. 2010 Dec;128(12):1533-8. doi: 10.1001/archophthalmol.2010.272.'}, {'pmid': '22464364', 'type': 'RESULT', 'citation': 'Chou KT, Huang CC, Tsai DC, Chen YM, Perng DW, Shiao GM, Lee YC, Leu HB. Sleep apnea and risk of retinal vein occlusion: a nationwide population-based study of Taiwanese. Am J Ophthalmol. 2012 Jul;154(1):200-205.e1. doi: 10.1016/j.ajo.2012.01.011. Epub 2012 Mar 30.'}, {'pmid': '27051260', 'type': 'RESULT', 'citation': 'Kwon HJ, Kang EC, Lee J, Han J, Song WK. Obstructive Sleep Apnea in Patients with Branch Retinal Vein Occlusion: A Preliminary Study. Korean J Ophthalmol. 2016 Apr;30(2):121-6. doi: 10.3341/kjo.2016.30.2.121. Epub 2016 Mar 25.'}, {'pmid': '30188014', 'type': 'RESULT', 'citation': 'Agard E, El Chehab H, Vie AL, Voirin N, Coste O, Dot C. Retinal vein occlusion and obstructive sleep apnea: a series of 114 patients. Acta Ophthalmol. 2018 Dec;96(8):e919-e925. doi: 10.1111/aos.13798. Epub 2018 Sep 6.'}]}, 'descriptionModule': {'briefSummary': 'This study purpose is to evaluate the association between Retinal Vein Occlusion and Obstructive Sleep Apnea.', 'detailedDescription': 'There will be two groups of 50 patients. One with Retinal Vein Occlusion, and the other one, with no Retinal Vein Occlusion will be chosen from the consultation.\n\nThe compared group will be paired on different criteria including hypertension, ocular hypertension, diabetes, sex, age.\n\nThey will all spend a night at home with a Sleeping Monitor (Nox T3) in order to evaluate if they have an Obstructive Sleep Apnea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with an Retinal Vein Occlusion for one group (patients)\n* All patients with no Retinal Vein Occlusion for the other group (control)\n\nNon-inclusion Criteria:\n\n* minor\n* Severe Insomnia\n* Neuromuscular Disease with respiratory muscle impairment\n* Chronic opioid medication\n* Pregnancy women.\n* Patient under guardianship'}, 'identificationModule': {'nctId': 'NCT04011358', 'acronym': 'SASOVR', 'briefTitle': 'Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study', 'organization': {'class': 'OTHER', 'fullName': "Centre Hospitalier Régional d'Orléans"}, 'officialTitle': 'Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study', 'orgStudyIdInfo': {'id': 'CHRO-2018-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patient', 'description': 'Patient with Retinal Vein Occlusion', 'interventionNames': ['Other: Sleeping Monitor']}, {'type': 'OTHER', 'label': 'Patient control', 'description': 'Patient with no Retinal Vein Occlusion', 'interventionNames': ['Other: Sleeping Monitor']}], 'interventions': [{'name': 'Sleeping Monitor', 'type': 'OTHER', 'description': 'to evaluate obstructive sleep apnea', 'armGroupLabels': ['Patient', 'Patient control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45067', 'city': 'Orléans', 'country': 'France', 'facility': "CHR d'Orléans", 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}], 'overallOfficials': [{'name': 'Pierre BONICEL, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHR Orléans'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre Hospitalier Régional d'Orléans", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}