Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-04-23 @ 1:01 PM
Study NCT ID:
NCT02323256
Status:
COMPLETED
Last Update Posted:
2025-08-11
First Post:
2014-10-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurophysiological Measures of Auditory Perception and Rehabilitation in Cochlear Implanted Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003638', 'term': 'Deafness'}], '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2014-10-15', 'studyFirstSubmitQcDate': '2014-12-22', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amplitude of auditory steady state responses ASSR', 'timeFrame': 'one year at least after CI activation'}, {'measure': 'Spectro-temporal analysis of speech-ABR', 'timeFrame': 'one year at least after CI activation'}, {'measure': 'Acoustic Change Complex ACC', 'timeFrame': 'one year at least after CI activation', 'description': 'Amplitudes and latencies of ACC'}, {'measure': 'amplitudes and latencies of P1/N1/P2 complex and Mismatch Negativity MMN', 'timeFrame': 'one year at least after CI activation'}, {'measure': 'Evolution of amplitude of auditory steady state responses ASSR', 'timeFrame': '1 month, 3 months, 6 months, 9 months and 12 months after CI activation', 'description': 'Evolution of ASSR amplitudes as a function of time during the first year of CI activation in newly implanted patients'}, {'measure': 'Evolution of spectro-temporal analysis of speech-ABR', 'timeFrame': '1 month, 3 months, 6 months, 9 months and 12 months after CI activation', 'description': 'Evolution of spectro-temporal analysis of speech-ABR as a function of time during the first year of CI activation in newly implanted patients'}, {'measure': 'Acoustic Change Complex ACC', 'timeFrame': '1 month, 3 months, 6 months, 9 months and 12 months after CI activation', 'description': 'Evolution of amplitudes and latencies of ACC as a function of time during the first year of CI activation in newly implanted patients'}, {'measure': 'amplitudes and latencies of P1/N1/P2 complex and Mismatch Negativity MMN', 'timeFrame': '1 month, 3 months, 6 months, 9 months and 12 months after CI activation', 'description': 'Evolution of amplitudes and latencies of P1N1P2 and MMN as a function of time during the first year of CI activation in newly implanted patients'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cochlear implant', 'deafness', 'audiometry', 'speech perception', 'severe to profound deafness restored with cochlear implantation'], 'conditions': ['Deafness']}, 'referencesModule': {'references': [{'pmid': '28692981', 'type': 'RESULT', 'citation': 'Attina V, Mina F, Stahl P, Duroc Y, Veuillet E, Truy E, Thai-Van H. A New Method to Test the Efficiency of Cochlear Implant Artifacts Removal From Auditory Evoked Potentials. IEEE Trans Neural Syst Rehabil Eng. 2017 Dec;25(12):2453-2460. doi: 10.1109/TNSRE.2017.2723952. Epub 2017 Jul 6.'}]}, 'descriptionModule': {'briefSummary': 'This study aims at investigating new automatic fitting techniques for cochlear implant patients based on objective measures. For this reason, the evolution of these neurophysiological measures, expressing the encoding of pure tones and speech, will be characterized in cochlear implanted patients as a function of post-implantation time and will be compared to those of normal hearing subjects. Moreover, the effect of auditory training with new tools based on serious games will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* native French speaker\n* no medical treatment for behavior or neurological disorders\n* normal or corrected vision\n* right-handed\n* normal ORL examination\n* valid affiliation to social security\n* absence of participation to another study\n\nFor the cochlear implanted patients:\n\n* aged from 1 to 70\n* bilateral severe to profound deafness\n* cochlear implant\n* congenital deafness, pre or post lingual\n\nFor the normal-hearing subjects:\n\n* Aged from 18 to 70\n* Normal tonal audiometry\n\nExclusion Criteria:\n\n* No signed consent\n* Treatment for depression, epilepsy, Parkinson's or Alzheimer's disease\n* Physical health deficiency\n* Mental retardation\n* Neurological or psychiatric disease incompatible with the testing procedure\n* Schooling in a foreign language\n* Foreign language spoken at home with both parents\n* Invalid social security\n* For the normal hearing subjects, no known hearing deficits"}, 'identificationModule': {'nctId': 'NCT02323256', 'acronym': 'NEUROSYLLABIC', 'briefTitle': 'Neurophysiological Measures of Auditory Perception and Rehabilitation in Cochlear Implanted Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Neurophysiological Measures During Sound and Speech Perception in Cochlear Implanted Patients and Development of New Speech Rehabilitation Tools', 'orgStudyIdInfo': {'id': '2014.857'}, 'secondaryIdInfos': [{'id': '2014-A00345-42', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'newly cochlear implanted adult patients', 'description': 'longitudinal group', 'interventionNames': ['Other: Auditory steady-state response ASSR', 'Other: Speech-ABR', 'Other: Acoustic Change Complex ACC', 'Other: P1-N1-P2 complex and Mismatch Negativity MMN']}, {'type': 'EXPERIMENTAL', 'label': 'newly cochlear implanted children', 'description': 'longitudinal group', 'interventionNames': ['Other: Auditory steady-state response ASSR', 'Other: Speech-ABR', 'Other: Acoustic Change Complex ACC', 'Other: P1-N1-P2 complex and Mismatch Negativity MMN']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'cochlear implanted adult patients (CI>1 year)', 'description': 'transversal group', 'interventionNames': ['Other: Auditory steady-state response ASSR', 'Other: Speech-ABR', 'Other: Acoustic Change Complex ACC', 'Other: P1-N1-P2 complex and Mismatch Negativity MMN']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'normal hearing adult subjects', 'description': 'transversal group', 'interventionNames': ['Other: Auditory steady-state response ASSR', 'Other: Speech-ABR', 'Other: Acoustic Change Complex ACC', 'Other: P1-N1-P2 complex and Mismatch Negativity MMN']}], 'interventions': [{'name': 'Auditory steady-state response ASSR', 'type': 'OTHER', 'description': 'comparison of ASSR amplitudes in response to amplitude-modulated sounds delivered at different intensities', 'armGroupLabels': ['cochlear implanted adult patients (CI>1 year)', 'newly cochlear implanted adult patients', 'newly cochlear implanted children', 'normal hearing adult subjects']}, {'name': 'Speech-ABR', 'type': 'OTHER', 'otherNames': ['comparison of spectro-temporal analysis of speech-ABR generated in response to speech syllables'], 'armGroupLabels': ['cochlear implanted adult patients (CI>1 year)', 'newly cochlear implanted adult patients', 'newly cochlear implanted children', 'normal hearing adult subjects']}, {'name': 'Acoustic Change Complex ACC', 'type': 'OTHER', 'description': 'comparison of ACC complex in response to changes within speech stimulation', 'armGroupLabels': ['cochlear implanted adult patients (CI>1 year)', 'newly cochlear implanted adult patients', 'newly cochlear implanted children', 'normal hearing adult subjects']}, {'name': 'P1-N1-P2 complex and Mismatch Negativity MMN', 'type': 'OTHER', 'description': 'comparison of amplitudes and latencies of P1-N1-P2 complex and MMN generated in response to the detection of changes in a series of auditory stimulation', 'armGroupLabels': ['cochlear implanted adult patients (CI>1 year)', 'newly cochlear implanted adult patients', 'newly cochlear implanted children', 'normal hearing adult subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69003', 'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de Lyon - Hopital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}