Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-28 @ 7:37 AM
Study NCT ID:
NCT05666466
Status:
UNKNOWN
Last Update Posted:
2022-12-30
First Post:
2022-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Noninvasive Diagnostic Techniques in Determination of Site of Lesion of Auditory Neuropathy Spectrum Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-03-18', 'releaseDate': '2025-02-26'}], 'estimatedResultsFirstSubmitDate': '2025-02-26'}}, 'conditionBrowseModule': {'meshes': [{'id': 'C538268', 'term': 'Auditory neuropathy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-29', 'studyFirstSubmitDate': '2022-12-17', 'studyFirstSubmitQcDate': '2022-12-17', 'lastUpdatePostDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'determination of site of lesion of ANSD', 'timeFrame': 'one and half year', 'description': 'differentiation between presynaptic and postsynaptic types of ANSD'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['auditory neuropathy'], 'conditions': ['Auditory Neuropathy']}, 'descriptionModule': {'briefSummary': 'cross-sectional study of population who have ANSD', 'detailedDescription': 'Cross-sectional nonivasive study including study and control group aiming to determine site of lesion of auditory neuropathy spectrum disorder either presynaptic or postsynaptic by using electrophysiological measures'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '25 participants aged between 12 to 50 years old with disproportionate SRS to PTA level, ABR may be absent or with disturbed waves or wave 5 could be detected at high intense stimulus, OAE and CM could be present. CT and MRI are free', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 12 and 50 years OAE and CM could be present disproportionate SRS to PTA level\n\nExclusion Criteria:\n\nproportionate ABR to PTA level Proportionate SRS to PTA level\n\n* presnce ol lesions in CT or MRI'}, 'identificationModule': {'nctId': 'NCT05666466', 'briefTitle': 'Noninvasive Diagnostic Techniques in Determination of Site of Lesion of Auditory Neuropathy Spectrum Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Noninvasive Diagnostic Techniques in Determination of Site of Lesion of Auditory Neuropathy Spectrum Disorder(ANSD)', 'orgStudyIdInfo': {'id': 'Soh-Med-22-12-16'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'case group', 'description': 'age between 12 to 50 disproportionate SRS to PTA level presence of OAE presence of CM Normal MRI and CT', 'interventionNames': ['Diagnostic Test: extratympanic electrocochleograhy']}, {'label': 'control group', 'description': 'age and sex matched to study group Normal hearing sensitivity and excellent speech discrimination no CAPD', 'interventionNames': ['Diagnostic Test: extratympanic electrocochleograhy']}], 'interventions': [{'name': 'extratympanic electrocochleograhy', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['EchoG'], 'description': 'electrophysiological test', 'armGroupLabels': ['case group', 'control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82524', 'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohammed Abdel Gaffar, MD', 'role': 'CONTACT', 'email': 'dr_mghaffar@yahoo.com', 'phone': '00201099055507'}], 'facility': 'Sohag Faculty of Medicine', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Rania Khalil, MSc', 'role': 'CONTACT', 'email': 'rania.khalil@med.sohag.edu.eg', 'phone': '00201024493093'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Rania Fattouh Ahmad Khalil', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-02-26', 'type': 'RELEASE'}, {'date': '2025-03-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Rania Fattouh Ahmad Khalil, Principal investigator, Sohag University'}}}}