Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-30 @ 7:06 AM
Study NCT ID:
NCT06301568
Status:
RECRUITING
Last Update Posted:
2024-08-22
First Post:
2024-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Analysis of Long-term Speech Performance in Cochlear Implant Recipients Using Electro-acoustic Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-09-17', 'releaseDate': '2025-08-29'}], 'estimatedResultsFirstSubmitDate': '2025-08-29'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}], 'ancestors': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-21', 'studyFirstSubmitDate': '2024-03-04', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freiburger monosyllabic word recognition score in quiet', 'timeFrame': '12 months after device activation', 'description': 'Percent correct in the Freiburger Monosyllabic Word test'}], 'secondaryOutcomes': [{'measure': 'HSM sentence score or OlSa recognition score in quiet', 'timeFrame': '12 months after device activation', 'description': 'percent correct in either the HSM sentence test or the Oldenburger sentence test'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cochlear Hearing Loss']}, 'descriptionModule': {'briefSummary': 'This is a retrospective study designed to collect long-term speech perception results for cochlear implants recipients using electro-acoustic-stimulation as measured in the clinical routine and to confirm the performance of sound processors associated with acoustic earhooks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The studied population consists of all CI users implanted with a HiRes Ultra or HiRes Ultra 3D SlimJ between January 2017 and August 2022 and using an acoustic earhook at the Medical University of Hannover in Germany (MHH)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being implanted with HiRes Ultra or HiRes Ultra 3D SlimJ\n* Being a user of the "acoustic earhook" system\n* Having provided informed consent regarding use of his/her data for research.\n\nExclusion Criteria:\n\n* no exclusion criteria'}, 'identificationModule': {'nctId': 'NCT06301568', 'briefTitle': 'Retrospective Analysis of Long-term Speech Performance in Cochlear Implant Recipients Using Electro-acoustic Stimulation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Advanced Bionics AG'}, 'officialTitle': 'Retrospective Analysis of Long-term Speech Performance in Cochlear Implant Recipients Using Electro-acoustic Stimulation', 'orgStudyIdInfo': {'id': 'ABIntl-23-12'}}, 'contactsLocationsModule': {'locations': [{'zip': 'D-30625', 'city': 'Hanover', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Andreas Büchner', 'role': 'CONTACT'}], 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}], 'centralContacts': [{'name': 'Andreas Büchner', 'role': 'CONTACT', 'email': 'buechner.andreas@mh-hannover.de', 'phone': '49 511 532 8589'}, {'name': 'Kliesch Sven', 'role': 'CONTACT', 'email': 'Kliesch.Sven@mh-hannover.de', 'phone': '49 511 532 8069'}], 'overallOfficials': [{'name': 'Andreas Büchner', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hannover Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Advanced Bionics AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-08-29', 'type': 'RELEASE'}, {'date': '2025-09-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Advanced Bionics AG'}}}}