Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-01-04 @ 5:13 PM
Study NCT ID:
NCT05942261
Status:
COMPLETED
Last Update Posted:
2024-11-27
First Post:
2023-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rehabilitation Methods of Children With Cochlear Implant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-25', 'studyFirstSubmitDate': '2023-07-04', 'studyFirstSubmitQcDate': '2023-07-04', 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Methods', 'timeFrame': '3 months', 'description': 'Describe which methods are used today in the rehabilitation of the deaf child with a cochlear implant.'}], 'secondaryOutcomes': [{'measure': 'Prevalence', 'timeFrame': '2 months', 'description': 'Describe the prevalence of the different methodologies in relation to the clinical characteristics of the patients.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cochlear implant', 'deafness', 'rehabilitation'], 'conditions': ['Deafness Neurosensory']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to describe the type of the rehabilitation method for italian children with cochlear implant . The main questions are:\n\nWhat is the most used rehabilitation methods in implanted children? Which is the prevalence of each method related to the clinical features of the patients?', 'detailedDescription': 'The cochlear implant represents the gold standard in the treatment of children with bilateral severe-profound deafness. However, the current Italian and international guidelines do not address the issue of rehabilitation and how the different rehabilitation methods should be applied in relation to the different clinical pictures. The aim of this study is therefore to describe which methods are used today in the rehabilitation of deaf children with cochlear implants followed at the Phoniatrics and Speech Therapy service of the A. Gemelli Polyclinic Foundation. The creation of a questionnaire directed to the speech therapist who treats the specific patient is available in order to collect data concerning the characteristics of the setting and the rehabilitation method in relation to the most applied methodologies, i.e. Auditory-verbal therapy, oral-cognitive therapy, bimodal method and the Drežančić method.\n\nInclusion Criteria:\n\n* Children diagnosed with severe-profound hearing loss and cochlear implant carriers followed at the Fondazione Policlinico universitario a. Gemelli in the last 10 years;\n* Age \\>12 months and \\<10 years\n\nExclusion Criteria:\n\n* Children diagnosed with mild to moderate hearing loss without a cochlear implant;\n* Age \\<12 months and \\>10 years\n\nOutcomes measures\n\n* Describe which methods are used today in the rehabilitation of the deaf child with a cochlear implant\n* Describe the prevalence of the different methodologies in relation to the clinical characteristics of the patients.\n\nEndpoints:\n\n-% distribution of the 4 rehabilitation methods: cognitive oralism, verb-tonal, Auditory-Verbal therapy and bimodal\n\n\\- % distribution of the 4 rehabilitation methods: cognitive oralism, verbal-tonal, Auditory-Verbal Therapy and bimodal in relation to the clinical characteristics of the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children diagnosed with severe-profound hearing loss and cochlear implant carriers followed at the Fondazione Policlinico Universitario A. Gemelli, Rome', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with severe to profound hearing loss who underwent cochlear implant placement surgery in the last 10 years;\n* Age \\>12 months and \\<10 years\n\nExclusion Criteria:\n\n* Patients diagnosed with mild to moderate hearing loss without a cochlear implant\n* Age \\<12 months and \\>10 years'}, 'identificationModule': {'nctId': 'NCT05942261', 'acronym': 'MRSI', 'briefTitle': 'Rehabilitation Methods of Children With Cochlear Implant', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Rehabilitation Methods of Children With Cochlear Implant: a Cross-sectional Survey', 'orgStudyIdInfo': {'id': '5685'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Survey to collect data', 'type': 'OTHER', 'description': 'The study is a survey aimed to collect data about rehabilitation methods'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'state': 'RM', 'country': 'Italy', 'facility': 'Fondazione Policlinico Universitario A. Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'mari Giorgia', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}