Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT00960102
Status:
UNKNOWN
Last Update Posted:
2022-08-17
First Post:
2009-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Children's Bilateral Cochlear Implantation in Finland
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003638', 'term': 'Deafness'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003054', 'term': 'Cochlear Implants'}, {'id': 'D006310', 'term': 'Hearing Aids'}], 'ancestors': [{'id': 'D058117', 'term': 'Neural Prostheses'}, {'id': 'D058542', 'term': 'Implantable Neurostimulators'}, {'id': 'D004567', 'term': 'Electrodes, Implanted'}, {'id': 'D004566', 'term': 'Electrodes'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D012682', 'term': 'Sensory Aids'}, {'id': 'D000076251', 'term': 'Wearable Electronic Devices'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-16', 'studyFirstSubmitDate': '2009-08-14', 'studyFirstSubmitQcDate': '2009-08-14', 'lastUpdatePostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of auditory performance skills of bilaterally or bimodally implanted children or children with bilateral hearing aids', 'timeFrame': 'Various time points up to 5 years hearing age'}], 'secondaryOutcomes': [{'measure': 'To compare post-operative speech perception ability, language acquisition, and speech production', 'timeFrame': 'Various time points up to 5 years hearing age'}, {'measure': 'To compare speech recognition performance', 'timeFrame': 'Various time points up to 5 years hearing age'}, {'measure': 'Quality of life and functional communicative performance assessed by parental proxy measures, and health economical assessment', 'timeFrame': 'Various time points up to 5 years hearing age'}, {'measure': 'To evaluate operative and post-operative complications, side-effects and device failures', 'timeFrame': 'Various time points up to 5 years hearing age'}, {'measure': 'To evaluate the differences in balance function', 'timeFrame': 'at 3 and 5 year age'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cochlear implantation', 'hearing aid'], 'conditions': ['Deafness', 'Hearing Loss']}, 'referencesModule': {'references': [{'pmid': '34260435', 'type': 'DERIVED', 'citation': 'Valimaa TT, Kunnari S, Aarnisalo AA, Dietz A, Hyvarinen A, Laitakari J, Mykkanen S, Rimmanen S, Salonen J, Sivonen V, Tennila T, Tsupari T, Vikman S, Virokannas N, Laukkanen-Nevala P, Tolonen AK, Tuohimaa K, Lopponen H. Spoken Language Skills in Children With Bilateral Hearing Aids or Bilateral Cochlear Implants at the Age of Three Years. Ear Hear. 2022 Jan/Feb;43(1):220-233. doi: 10.1097/AUD.0000000000001092.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate short and long term outcomes (benefits and side-effects) of bilateral cochlear implantation and bilateral hearing aid rehabilitation in Finnish children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Congenital severe or profound bilateral hearing impairment\n* No functional benefit from conventional hearing aids (minimum 3 months trial)\n* Radiologically (CT,MRI) patent inner ears and normal central auditory pathways\n* Family is motivated for rehabilitation programme and gives a written consent\n* Finnish or Swedish as the primary language in the home\n\nExclusion Criteria:\n\n* A child has an additional anomaly or disability that may affect to his/her functional or neurological development\n* Inner ear anomaly\n* Mother's pregnancy duration less than 32 weeks"}, 'identificationModule': {'nctId': 'NCT00960102', 'acronym': 'FinBiCI', 'briefTitle': "Children's Bilateral Cochlear Implantation in Finland", 'organization': {'class': 'OTHER', 'fullName': 'Kuopio University Hospital'}, 'officialTitle': "Children's Bilateral Cochlear Implantation in Finland: a Prospective, Controlled, Multicenter Study", 'orgStudyIdInfo': {'id': 'KUH5551819'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'bilateral cochlear implant', 'interventionNames': ['Device: cochlear implant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'cochlear implant and hearing aid', 'interventionNames': ['Device: cochlear implant', 'Device: hearing aid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bilateral hearing aid', 'interventionNames': ['Device: hearing aid']}], 'interventions': [{'name': 'cochlear implant', 'type': 'DEVICE', 'description': 'Multichannel Nucleus cochlear implant', 'armGroupLabels': ['bilateral cochlear implant', 'cochlear implant and hearing aid']}, {'name': 'hearing aid', 'type': 'DEVICE', 'description': 'Phonak hearing aid', 'armGroupLabels': ['bilateral hearing aid', 'cochlear implant and hearing aid']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helsinki', 'country': 'Finland', 'facility': 'Department of Otorhinolaryngology, Helsinki University Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '70211', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'Department of Otorhinolaryngology, Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'city': 'Oulu', 'country': 'Finland', 'facility': 'Department of Otorhinolaryngology, Oulu University Hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'city': 'Turku', 'country': 'Finland', 'facility': 'Department of Otorhinolaryngology, Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Heikki J Löppönen, M.D.,Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Otorhinolaryngology, Institute of Clinical Medicine, Kuopio University and Kuopio University Hospital, Finland'}, {'name': 'Taina T Välimaa, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Humanities, Logopedics, University of Oulu, Finland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Eastern Finland', 'class': 'OTHER'}, {'name': 'Hospital District of Helsinki and Uusimaa', 'class': 'OTHER'}, {'name': 'University of Helsinki', 'class': 'OTHER'}, {'name': 'Oulu University Hospital', 'class': 'OTHER'}, {'name': 'University of Oulu', 'class': 'OTHER'}, {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, {'name': 'Tampere University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.,Prof.', 'investigatorFullName': 'Heikki Lopponen', 'investigatorAffiliation': 'Kuopio University Hospital'}}}}