Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-27 @ 9:02 PM
Study NCT ID:
NCT06894303
Status:
RECRUITING
Last Update Posted:
2025-03-25
First Post:
2025-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 51}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2025-03-19', 'studyFirstSubmitQcDate': '2025-03-19', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '50% SRT measured as signal to noise ratio in DB (French Matrix test in noise)', 'timeFrame': 'one-month chronic use of remotely fitted sound processor', 'description': 'The primary efficacy objective is to demonstrate that speech recognition in noise after remote fitting is no worse than speech recognition in noise after in-office fitting.'}], 'secondaryOutcomes': [{'measure': 'Score in the Lafon phoneme test in quiet', 'timeFrame': 'one-month chronic use of remotely fitted sound processor', 'description': 'The secondary efficacy objective is to demonstrate that speech recognition in quiet after remote fitting is no worse than speech recognition in quiet after in-office fitting.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cochlear Hearing Loss']}, 'descriptionModule': {'briefSummary': "This is a prospective and monocentric clinical investigation, non-interventional and non-randomized. The overall goal of this clinical study is to generate additional clinical data confirming the safety and efficacy of the remote programming functionality of Target CI version 1.5 and the AB Remote Support app. Hearing outcomes are expected to be similar whether a study subject's sound processor is programmed in the traditional method in the audiologist's office or whether programming is performed via remote fitting. Therefore, the study uses a non-inferiority design to determine whether sentence recognition in noise is no worse with remote fitting than in an in-office setting."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Advanced Bionics adults CI users', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to provide informed consent\n* Ability to give feedback on hearing impressions\n* Aged 18 years of age or older\n* Implanted with a HiResolution Bionic Ear System (HiRes 90K or HiRes 90K Advantage or HiRes Ultra or HiRes Ultra 3D) on at least one side\n\n * Group 1 - Unilateral: no hearing device except contralateral routing of signals (CROS) device on the contralateral side\n * Group 2 - Bilateral: implanted on both sides\n * Group 3 - Bimodal: hearing aid on the contralateral side\n* Minimum of six months of cochlear implant experience\n* Minimum of one month experience with a Naída CI M or Sky CI M sound processor\n* Fluent in French language\n* Ability to be tested via speech perception test in noise\n* Smartphone user\n\nExclusion Criteria:\n\n* Clinical presentation indicative of potential implanted device malfunction\n* Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the Investigator\n* Unwillingness or inability of subject to comply with all investigational requirements as determined by the Investigator\n\nPregnancy and breast-feeding are not exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT06894303', 'briefTitle': 'Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-up', 'organization': {'class': 'INDUSTRY', 'fullName': 'Advanced Bionics AG'}, 'officialTitle': 'Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-up', 'orgStudyIdInfo': {'id': 'ABInt-24-23'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Unilateral users', 'interventionNames': ['Device: Target CI v1.5 remote programming']}, {'label': 'Group 2', 'description': 'Bilateral users', 'interventionNames': ['Device: Target CI v1.5 remote programming']}, {'label': 'Group 3', 'description': 'Bimodal users', 'interventionNames': ['Device: Target CI v1.5 remote programming']}], 'interventions': [{'name': 'Target CI v1.5 remote programming', 'type': 'DEVICE', 'description': 'Use of the remote programming function of Target CI v1.5 and the AB remote support application', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Isabelle Mosnier', 'role': 'CONTACT', 'email': 'isabelle.mosnier@aphp.fr', 'phone': '+33142162606'}], 'facility': 'Groupement Hospitalier Pitié Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Advanced Bionics AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}