Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT05543135
Status:
UNKNOWN
Last Update Posted:
2022-09-16
First Post:
2022-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Aetiology of Asymmetrical Hearing Loss: A Retro-spective Study Thesis Submitted for Partial Fulfillment of Master Degree in Audio-Vestibular Medicine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-10-11', 'releaseDate': '2024-07-10'}], 'estimatedResultsFirstSubmitDate': '2024-07-10'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-14', 'studyFirstSubmitDate': '2022-09-14', 'studyFirstSubmitQcDate': '2022-09-14', 'lastUpdatePostDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asymmetrical hearing loss', 'timeFrame': '1 year', 'description': 'asymmetrical hearing loss using basic audiological evalution \\&imaging'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asymmetrical Hearing Loss']}, 'referencesModule': {'references': [{'pmid': '18453885', 'type': 'BACKGROUND', 'citation': 'Dunn CC, Tyler RS, Oakley S, Gantz BJ, Noble W. Comparison of speech recognition and localization performance in bilateral and unilateral cochlear implant users matched on duration of deafness and age at implantation. Ear Hear. 2008 Jun;29(3):352-9. doi: 10.1097/AUD.0b013e318167b870.'}, {'pmid': '18418281', 'type': 'BACKGROUND', 'citation': 'Margolis RH, Saly GL. Asymmetric hearing loss: definition, validation, and prevalence. Otol Neurotol. 2008 Jun;29(4):422-31. doi: 10.1097/MAO.0b013e31816c7c09.'}, {'pmid': '22045002', 'type': 'BACKGROUND', 'citation': 'Peng AW, Salles FT, Pan B, Ricci AJ. Integrating the biophysical and molecular mechanisms of auditory hair cell mechanotransduction. Nat Commun. 2011 Nov 1;2:523. doi: 10.1038/ncomms1533.'}, {'pmid': '23938209', 'type': 'BACKGROUND', 'citation': 'Plack CJ, Barker D, Hall DA. Pitch coding and pitch processing in the human brain. Hear Res. 2014 Jan;307:53-64. doi: 10.1016/j.heares.2013.07.020. Epub 2013 Aug 11.'}]}, 'descriptionModule': {'briefSummary': "Hearing loss maybe: -Symmetrical: in which the severity and pattern of hearing loss are the same in each ear. Or -Asymmetrical: is defined as binaural difference in bone conduction thresholds of \\>10 dB at two consecutive frequencies or \\>20 dB at one frequency (0.25-8.0 kHz), Poorer speech perception will often accompany poorer hearing and may be the reason for the patient's presentation .Unilateral or asymmetrical sensorineural hearing loss is important to discern, as it is an important risk factor for auditory nerve tumors (i.e. vestibular schwannoma) which is a life threatening condition, and in such cases further investigation is required (i.e. MRI scan) unless there is a known reason for the asymmetry, Several reports have recommended that further evaluation, especially expensive imaging studies, be conducted to rule out acoustic tumors when AHL is present"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'all patients with asymmetrical hearing loss with age ranging 6 years old and more.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 6 years old and more.\n* Sex: male and female.\n\nExclusion Criteria:\n\n* Age: less than 6 years old.\n* Patients with symmetrical hearing loss.'}, 'identificationModule': {'nctId': 'NCT05543135', 'briefTitle': 'Aetiology of Asymmetrical Hearing Loss: A Retro-spective Study Thesis Submitted for Partial Fulfillment of Master Degree in Audio-Vestibular Medicine', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Aetiology of Asymmetrical Hearing Loss: A Retro-spective Study Thesis Submitted for Partial Fulfillment of Master Degree in Audio-Vestibular Medicine', 'orgStudyIdInfo': {'id': 'Soh-Med-22-07-09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cases', 'description': 'patients with asymmetrical hearing loss', 'interventionNames': ['Diagnostic Test: basic audiological evaluation']}], 'interventions': [{'name': 'basic audiological evaluation', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['CT&MRI'], 'description': 'pure tone audiometry\\&immitancemetry', 'armGroupLabels': ['cases']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin, professor', 'role': 'CONTACT'}], 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Enas M Mahrous, resident doctor', 'role': 'CONTACT', 'email': 'inas_mahmoud_post@med.sohag.edu.eg', 'phone': '01096769904'}, {'name': 'Mohamed A Abdelrahman, professor', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor at audiovestibular unit Qena general hospital', 'investigatorFullName': 'Inas Mahmoud Mahrous', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-07-10', 'type': 'RELEASE'}, {'date': '2024-10-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Inas Mahmoud Mahrous, resident doctor at audiovestibular unit Qena general hospital, Sohag University'}}}}