Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-03-04 @ 10:25 PM
Study NCT ID:
NCT02880059
Status:
UNKNOWN
Last Update Posted:
2017-10-31
First Post:
2016-08-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence and Effects of Sleep Apnea on Intracerebral Aneurysms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D000783', 'term': 'Aneurysm'}], 'ancestors': [{'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': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-29', 'studyFirstSubmitDate': '2016-08-23', 'studyFirstSubmitQcDate': '2016-08-23', 'lastUpdatePostDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure medication', 'timeFrame': 'Baseline', 'description': 'Blood pressure medication at baseline will be accessed.'}, {'measure': 'Blood pressure', 'timeFrame': 'Baseline', 'description': 'Blood pressure on baseline visit will be accessed.'}], 'secondaryOutcomes': [{'measure': 'Subarachnoid hemorrhage', 'timeFrame': '5 years', 'description': 'Rate of aneurysm rupture and subarachnoid hemorrhage will be accessed annually.'}, {'measure': 'Increase in size of aneurysm', 'timeFrame': '5 years'}, {'measure': 'Change in blood pressure medication', 'timeFrame': '5 years', 'description': 'Blood pressure medication will be accessed on annual follow-up for up to 5 years.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sleep Apnea, Aneurysm, Subarachnoid Hemorrhage, Blood Pressure.'], 'conditions': ['Sleep Apnea (Defined as Apnea Hypopnea Index > 5/h)', 'Intracranial Aneurysm Size', 'Blood Pressure Medication', 'Comorbidities', 'Complications (Subarachnoid Hemorrhage)']}, 'referencesModule': {'references': [{'pmid': '35088709', 'type': 'DERIVED', 'citation': 'Zaremba S, Albus L, Hadjiathanasiou A, Vatter H, Wullner U, Guresir E. Aneurysm size and blood pressure severity in patients with intracranial aneurysms and sleep apnea. J Clin Sleep Med. 2022 Jun 1;18(6):1539-1545. doi: 10.5664/jcsm.9906.'}]}, 'descriptionModule': {'briefSummary': 'Patients with intracerebral aneurysm will be screened for sleep apnea using out of center polysomnography/polygraphy. Baseline blood pressure and medication will be assessed. Patients will be followed for up to 5 years to examine the increase in aneurysm size, rupture rate and changes in medication.', 'detailedDescription': 'Patient presenting to the outpatient center for neurological of neurosurgical management of intracerebral aneurysm will be recruited. Sleep apnea will be assessed by questionnaire and out of center polygraph/polysomnography. Medication, comorbidities and blood pressure will be recorded. Change in aneurysm size and blood pressure medication will be evaluated annually for up to 5 years. Frequency of subarachnoid hemorrhage and increase in aneurysm size will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients 18yrs. and older with intracerebral aneurysm.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intracerebral aneurysm\n* Age \\>= 18yrs.\n* Ability to give informed consent\n\nExclusion Criteria:\n\n* Stroke within 3 month of study inclusion.'}, 'identificationModule': {'nctId': 'NCT02880059', 'acronym': 'IESA', 'briefTitle': 'Incidence and Effects of Sleep Apnea on Intracerebral Aneurysms', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bonn'}, 'officialTitle': 'Incidence and Effects of Sleep Apnea on Intracerebral Aneurysms - IESA-Study', 'orgStudyIdInfo': {'id': 'IESA-Study'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cardiorepiratory Polygraphy', 'type': 'DEVICE', 'otherNames': ['Sleep Apnea Screening'], 'description': 'Sleep apnea screening by out-of-center polysomnography/polygraphy'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-53105', 'city': 'Bonn', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Sebastian Zaremba, MD', 'role': 'CONTACT', 'email': 'sebastian.zaremba@ukb.uni-bonn.de', 'phone': '+49-228-287-16566'}, {'name': 'Erdem Gueresir, MD, PhD', 'role': 'CONTACT', 'email': 'erden.güresir@ukb.uni-bonn.de', 'phone': '+49-228-287-16566'}, {'name': 'Erdem Gueresir, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Neurology and Department of Neurosurgery', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}], 'centralContacts': [{'name': 'Sebastian Zaremba, MD', 'role': 'CONTACT', 'email': 'zaremba.sebastian@gmx.net', 'phone': '+49(0)228-287-16566'}, {'name': 'Erdem Guersir, MD, PhD', 'role': 'CONTACT', 'email': 'erdem.gueresir@ukb.uni-bonn.de', 'phone': '+49(0)228-287-16566'}], 'overallOfficials': [{'name': 'Erdem Gueresir, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vice Chair of Department of Neurosurgery'}, {'name': 'Sebastian Zaremba, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Staff Physician'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bonn', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med. Sebastian Zaremba', 'investigatorFullName': 'Sebastian Zaremba', 'investigatorAffiliation': 'University Hospital, Bonn'}}}}