Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2026-01-03 @ 5:19 AM
Study NCT ID:
NCT00313092
Status:
TERMINATED
Last Update Posted:
2015-10-02
First Post:
2006-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Obstructive Sleep Apnea Syndrome in Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D005901', 'term': 'Glaucoma'}], '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'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'whyStopped': 'recruiting problems', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-01', 'studyFirstSubmitDate': '2006-04-10', 'studyFirstSubmitQcDate': '2006-04-10', 'lastUpdatePostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['OSAS', 'glaucoma', 'MMP'], 'conditions': ['Obstructive Sleep Apnea Syndrome', 'Glaucoma']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to determine if plasma matrix-metalloproteinase activity can predict glaucoma in patients with OSAS and if the level of plasma matrix-metalloproteinase activity will decrease after one month of nCPAP-treatment.', 'detailedDescription': 'Glaucoma is a leading cause of blindness world-wide. Chronic primary open-angle glaucoma is the most common form among Caucasian patients. The key feature of glaucoma is damage to the optic nerve head, which is not necessarily related to an increased intraocular pressure. The prevalence of glaucoma among the patients with sleep apnoea was 7,2%: normal-tension glaucoma 2,9%, primary open-angle glaucoma 4,3%. The prevalence of obstructive sleep apnoea syndrome (OSAS) is around 4-10% for men and 2-4% for women. Matrix metalloproteinases (MMPs) substrates include essentially all extracellular matrix components as well as a wide array of molecules involved in intracellular adhesion, cell-matrix interaction, and cell signalling. However, MMPs effects are not restricted to extracellular matrix degradation. The prevalence of increased MMP in patients with OSAS and its predicting value for an additional glaucoma are not known. Further, we do not know if treatment of OSAS with nasal continuous positive air pressure(nCPAP) can decrease the MMP activity. With this study, we want to determine the prevalence of MMP activity and the prevalence of glaucoma in patients with OSAS. Further, we want to investigate if a nCPAP treatment period of four weeks decreases the MMP activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with sleep apnoe syndrom', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* OSAS planned begin of a nCPAP treatment\n\nExclusion Criteria:\n\n* Current malignancy\n* Oral steroids'}, 'identificationModule': {'nctId': 'NCT00313092', 'briefTitle': 'Obstructive Sleep Apnea Syndrome in Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Does Plasma Matrix-metalloproteinase Activity Predict Glaucomas in Patients With OSAS (Obstructive Sleep Apnea Syndrome) and Does the Level of Plasma Matrix-metalloproteinase Activity Decrease After One Month of nCPAP-treatment', 'orgStudyIdInfo': {'id': '045-LEJ-2004-002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'nCPAP treatment', 'type': 'DEVICE', 'description': 'treatment with positive air pressure during night'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': 'University Hospital Basel, Eye Clinic', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Selim Orgül, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Eye Clinic Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Selim Orguel', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Selim Orguel', 'investigatorAffiliation': 'University Hospital, Basel, Switzerland'}}}}