Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
Study NCT ID:
NCT05360212
Status:
RECRUITING
Last Update Posted:
2025-08-12
First Post:
2022-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anatomy-based Fitting in Cochear 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': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2022-04-23', 'studyFirstSubmitQcDate': '2022-04-28', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Result from the speech test in noise (S0N0)', 'timeFrame': 'Month 6', 'description': 'Speech perception evaluation with CI-only (MATRIX) with signal and noise in the same channel'}, {'measure': 'Results from speech tests in noise with spatially separated loudspeakers', 'timeFrame': 'Month 6', 'description': 'Speech perception evaluation with CI-only (MATRIX) with signal and noise in different channels'}, {'measure': 'Result from the speech test in quiet (S0)', 'timeFrame': 'Month 6', 'description': 'Speech perception evaluation with CI-only (disyllables)'}], 'secondaryOutcomes': [{'measure': 'Results of quality of sound', 'timeFrame': 'Month 6', 'description': 'Subjective results through Hearing Implant Sound Quality Index 19. Scores range 19-133 points. Higher scores mean a better outcome.'}, {'measure': 'Results of quality of life in challenging situations', 'timeFrame': 'Month 6', 'description': 'Subjective results through Listening effort questionnaire. Scores range 21-93 points. Higher scores mean a better outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cochlear Implant', 'Outcomes', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'In this study, the performance with the CI is investigated over time in three groups of freshly implanted CI users. Both the standard frequency-band distribution and anatomy-based fitting will be used to compare outcomes.', 'detailedDescription': 'In this study, the performance with the CI is investigated over time in three groups of freshly implanted CI users. The first group is fitted using the standard frequency-band distribution as implemented in MAESTRO 9. In the second group of users, an anatomy-based frequency distribution is used as per anatomy-based fitting in MAESTRO 9. The performance with anatomy-based fitting is assessed by comparing performance with the CI in these two groups over time.\n\nThe third group constitutes the within-subject design. These subjects are both fitting using the standard frequency-band distribution and the anatomy-based frequency distribution in MAESTRO 9. So, subjects will have both study maps on their audio processor throughout the whole study. They will have to change weekly between both fittings: standard fitting and anatomy-based fitting. Here, the performance with anatomy-based fitting is assessed by comparing performance with standard fitting and anatomy-based fitting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years\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 or FlexSoft electrode\n* Subject planned to receive a SONNET 2 /RONDO3 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 Spanish\n* Signed and dated ICF before the start of any study-specific procedure\n\nSpecific inclusion criteria for the possible study groups • Bilateral CI users: Bilateral CI implantation SONNET 2/RONDO3 audio processor on the first ear implanted\n\n* 40% speech recognition a monosyllabic word Test in quiet at 65 dB SPL (last time tested) on the already implanted side\n* 40% speech recognition in a sentence test in noise (10 dB SNR) on the already implanted side First activation of the already implanted side between 3 and 12 months prior to study inclusion\n\n • Unilateral CI users: Unilateral CI implantation CI user with contralateral hearing ≥ 60 dB (PTA measured at 500, 1000, 2000, and 4000 Hz)\n\n • SSD CI users: Unilateral CI implantation CI user with contralateral hearing ≤30 dB (PTA measured at 500, 1000, 2000, and 4000 Hz) Interaural threshold gap ≥40 dB\n\n • Bimodal CI users: Unilateral CI implantation Contralateral ear adequately fitted with a hearing aid CI user with contralateral hearing ≥30 dB (PTA measured at 500, 1000, 2000, and 4000 Hz) CI user with contralateral hearing ≤55 dB (PTA measured at 500, 1000, 2000, and 4000 Hz) Interaural threshold gap ≥15 dB\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* Known allergic reactions to components of the investigational medical device\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': 'NCT05360212', 'briefTitle': 'Anatomy-based Fitting in Cochear Implant Users', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz'}, 'officialTitle': 'Anatomy-based Fitting in Unexperienced Cochlear Implant Users. Programación Basada en la anatomía en Usuarios Nuevos de Implante Coclear.', 'orgStudyIdInfo': {'id': 'PI-6128'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Standard fitting', 'description': 'The first group is fitted using the standard frequency-band distribution as implemented in MAESTRO 9', 'interventionNames': ['Procedure: Standard Fitting']}, {'type': 'EXPERIMENTAL', 'label': 'Anatomy-based fitting', 'description': 'In the second group of users, an anatomy-based frequency distribution is used as per anatomy-based fitting in MAESTRO 9', 'interventionNames': ['Procedure: Anatomy-based fitting (ABF)']}, {'type': 'EXPERIMENTAL', 'label': 'Within-subject design: Standard fitting + ABF', 'description': 'The third group constitutes the within-subject design. These subjects are both fitting using the standard frequency-band distribution and the anatomy-based frequency distribution in MAESTRO 9. So, subjects will have both study maps on their audio processor throughout the whole study. They will have to change weekly between both fittings: standard fitting and anatomy-based fitting.', 'interventionNames': ['Procedure: Standard fitting+ ABF']}], 'interventions': [{'name': 'Anatomy-based fitting (ABF)', 'type': 'PROCEDURE', 'description': 'MAESTRO 9 can display the tonotopic frequency of each individual electrode channel imported from OTOPLAN to further support fitting based on these measures. The audiologist can set a frequency-band distribution that is more closely aligned to the tonotopic frequency distribution as imported from OTOPLAN.', 'armGroupLabels': ['Anatomy-based fitting']}, {'name': 'Standard Fitting', 'type': 'PROCEDURE', 'description': 'These group is fitted using the standard frequency-band distribution as implemented in MAESTRO 9.', 'armGroupLabels': ['Standard fitting']}, {'name': 'Standard fitting+ ABF', 'type': 'PROCEDURE', 'description': 'Patients of this group are both fitting using the standard frequency-band distribution and the anatomy-based frequency distribution in MAESTRO 9. So, subjects will have both study maps on their audio processor throughout the whole study. They will have to change weekly between both fittings: standard fitting and anatomy-based fitting. Here, the performance with anatomy-based fitting is assessed by comparing performance with standard fitting and anatomy-based fitting.', 'armGroupLabels': ['Within-subject design: Standard fitting + ABF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28046', 'city': 'Madrid', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Miryam Calvino', 'role': 'CONTACT', 'email': 'miryamcf@yahoo.com'}], 'facility': 'Hospital Universitario de La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Luis Lassaletta, PhD', 'role': 'CONTACT', 'email': 'llasaletta@salud.madrid.org', 'phone': '0034656898265'}, {'name': 'Miryam Calvino, PhD', 'role': 'CONTACT', 'email': 'miryamcf@yahoo.com', 'phone': '0034646354267'}], 'overallOfficials': [{'name': 'Luis Lassaletta, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz', 'class': 'OTHER'}, 'collaborators': [{'name': 'MED-EL Elektromedizinische Geräte GesmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Luis Lassaletta', 'investigatorAffiliation': 'Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz'}}}}