Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-02-20 @ 6:39 PM
Study NCT ID:
NCT01805167
Status:
UNKNOWN
Last Update Posted:
2013-03-06
First Post:
2013-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrophysiological Study of Interindividual Differences in Speech-understanding Among Cochlear Implant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}], 'ancestors': [{'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-03-05', 'studyFirstSubmitDate': '2013-02-22', 'studyFirstSubmitQcDate': '2013-03-05', 'lastUpdatePostDateStruct': {'date': '2013-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantify the interactions between electrical stimulation channels based vocal performance of implanted subjects, for different subjective levels of electrical stimulation.', 'timeFrame': 'At the inclusion - Day 0', 'description': 'The vocal performance will be noted in percentage of voice recognition in the silence and in the noise.\n\nAnd the electric interaction between the channels of stimulations will be estimated by the measure of the refractory period of the circuits of the hearing system with the PEAEP after stimulations of electrodes of intermediate situation in the cochlée (electrodes 11, 12 and 13)'}], 'secondaryOutcomes': [{'measure': 'Comparative study of PEAEP (Auditory Evoked Potentials Early electric) in vocal performance', 'timeFrame': 'At the inclusion - Day 0', 'description': 'Collection of the PEAEP after stimulation of 4 different electrodes distributed on the totality of door-electrode: generally, electrodes 4, 7, 10 and 13 will be stimulated. The amplitudes and the latencies of the waves II, III and V will be analyzed and compared with the vocal performances.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Subject with cochlear implant'], 'conditions': ['Hearing Loss']}, 'referencesModule': {'references': [{'pmid': '27149268', 'type': 'DERIVED', 'citation': 'Guevara N, Hoen M, Truy E, Gallego S. A Cochlear Implant Performance Prognostic Test Based on Electrical Field Interactions Evaluated by eABR (Electrical Auditory Brainstem Responses). PLoS One. 2016 May 5;11(5):e0155008. doi: 10.1371/journal.pone.0155008. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'Differences in speech-understanding and the quality of the subjective perception among cochlear implant patients (Digisonic SP) depends on numerous factors. The electrical field distribution (interaction between electrodes) could also explain the disparity of the performances? The objective of our study was to quantify the influence of the electrical field interactions between the channels of stimulation according to the vocal performances of the implanted subjects, for various subjective levels of electric stimulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject of French language\n* Subject with a moderate bilateral sensorineural hearing loss, severe to profound\n* Sensorineural hearing loss post-lingual (after onset of language acquisition)\n* Subject paired with the implant Neurelec (Appendix 1) for more than 9 months\n* Subject has received an appropriate setting under usual clinical follow-up\n* Elderly 18 to 75 years\n* Subject giving consent\n\nExclusion Criteria:\n\n* Sensorineural hearing loss pre-lingual\n* Deafness following a meningitis, or neurodegenerative diseases\n* Illiteracy\n* Pregnant women\n* Subject blind\n* Subject enjoying a measure of legal protection\n* Subject incapable of giving consent\n* Subject vulnerable'}, 'identificationModule': {'nctId': 'NCT01805167', 'briefTitle': 'Electrophysiological Study of Interindividual Differences in Speech-understanding Among Cochlear Implant Patients', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Electrophysiological Study of Interindividual Differences in Speech-understanding Among Cochlear Implant Patients', 'orgStudyIdInfo': {'id': '12-AOI-06'}, 'secondaryIdInfos': [{'id': '2012-A01374-39', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'subjects with a cochlear implant', 'interventionNames': ['Other: Electrophysiological study of the interindividual variability of vocal performance']}], 'interventions': [{'name': 'Electrophysiological study of the interindividual variability of vocal performance', 'type': 'OTHER', 'armGroupLabels': ['subjects with a cochlear implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicolas GUEVARA, Dr', 'role': 'CONTACT', 'email': 'guevara.n@chu-nice.fr'}, {'name': 'Nicolas Guevara, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'Nicolas GUEVARA, Dr', 'role': 'CONTACT', 'email': 'guevara.n@chu-nice.fr'}], 'overallOfficials': [{'name': 'Nicolas Guevara, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nice'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}