Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-01-02 @ 6:11 AM
Study NCT ID:
NCT05684393
Status:
UNKNOWN
Last Update Posted:
2023-01-13
First Post:
2023-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anatomy-based Fitting in Unexperienced Cochlear Implant Users
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'double blinded design: both the participant and the investigator have no information about the treatment group.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The performance with the CI is investigated over time in two groups of freshly implanted CI users. The first group is fitted using the standard frequency-band distribution as implemented in MAESTRO 9 fitting software. In the second group of users, an anatomy-based frequency distribution is used as per anatomy-based fitting in MAESTRO 9.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-04', 'studyFirstSubmitDate': '2023-01-04', 'studyFirstSubmitQcDate': '2023-01-04', 'lastUpdatePostDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Word recognition score (WRS)', 'timeFrame': '6 months', 'description': 'Percentage of correctly understood monosyllabic words from a list.'}], 'secondaryOutcomes': [{'measure': 'Speech reception threshold (SRT)', 'timeFrame': '6 months', 'description': 'German matrix sentence test - speech to noise ratio in dB.'}, {'measure': 'Pitch ranking', 'timeFrame': '6 months', 'description': 'Difference of the mean ranks for a set of frequencies presented to the tested CI ear and the reference ear.'}, {'measure': 'Perception of timbre', 'timeFrame': '6 months', 'description': 'Visual Analog Scale ratings describing the difference in timbre between the tested CI ear and the reference ear when listening to audio.'}, {'measure': 'Phoneme categorization', 'timeFrame': '6 months', 'description': 'Shape of the psychometric function describing the perception of the /s/-/ʃ/ continuum.'}, {'measure': 'Consonance/difference rating', 'timeFrame': '6 months', 'description': 'The degree of modulation of the pleasantness-score across the individual intervals.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Influence of Anatomy Based Frequency Mapping on Speech Outcomes and Hearing Related Measures']}, 'descriptionModule': {'briefSummary': "The present study investigates CI users' potential differences in speech tests, other performance measures (i.e. pitch-matching, perception of timbre and melodic intervals, consonance perception), and patient-reported outcome (i.e. questionnaires) between the clinical fitting map and anatomy-based fitting in two groups of CI users (one with standard fitting and one with anatomy-based fitting)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)\n* Post-OP CT scan of the CI electrode available\n* Subject implanted with MED-EL cochlear implant(s)\n* Subjects received a Flex28, FlexSoft and Standard electrode\n* Subject planned to receive a SONNET 2 or RONDO 3 audio processor on the newly implanted side\n* Audio processor not yet activated on the newly implanted side\n* The most apical active electrode contact has to be inserted at least 450°\n* Minimum of 10 active channels can be activated\n* Fluent in the language of the test centre\n* Signed and dated ICF before the start of any study-specific procedure\n\nExclusion Criteria:\n\n* Lack of compliance with any inclusion criteria\n* EAS user (user of an EAS audio processor)\n* Implanted with C40+, C40X and C40C\n* Implanted with an ABI or Split electrode array\n* Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study"}, 'identificationModule': {'nctId': 'NCT05684393', 'briefTitle': 'Anatomy-based Fitting in Unexperienced Cochlear Implant Users', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Anatomy-based Fitting in Unexperienced Cochlear Implant Users', 'orgStudyIdInfo': {'id': '2131/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anatomy based fitting', 'interventionNames': ['Other: frequency distribution type']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard fitting', 'interventionNames': ['Other: frequency distribution type']}], 'interventions': [{'name': 'frequency distribution type', 'type': 'OTHER', 'description': 'One group is fitted using channel filterbank frequency distribution based on anatomy data extracted from post-OP CT measurements. The second (control) group is fitted with the standard frequency distribution used in MAESTRO 9 fitting software.', 'armGroupLabels': ['Anatomy based fitting', 'Standard fitting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1180', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Dominik Riss, MD', 'role': 'CONTACT', 'email': 'dominik.riss@meduniwien.ac.at', 'phone': '+4314040033760'}, {'name': 'Dominik Riss, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Dominik Riss, MD', 'role': 'CONTACT', 'email': 'dominik.riss@meduniwien.ac.at', 'phone': '+43 1 40400 33760'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dominik Riss', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assoc.-Prof. Priv.-Doz. Dr. med.', 'investigatorFullName': 'Dominik Riss', 'investigatorAffiliation': 'Medical University of Vienna'}}}}