Children's Bilateral Cochlear Implantation in Finland (FinBiCI)
Primary Purpose
Deafness, Hearing Loss
Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
cochlear implant
hearing aid
Sponsored by
About this trial
This is an interventional treatment trial for Deafness focused on measuring cochlear implantation, hearing aid
Eligibility Criteria
Inclusion Criteria:
- Congenital severe or profound bilateral hearing impairment
- No functional benefit from conventional hearing aids (minimum 3 months trial)
- Radiologically (CT,MRI) patent inner ears and normal central auditory pathways
- Family is motivated for rehabilitation programme and gives a written consent
- Finnish or Swedish as the primary language in the home
Exclusion Criteria:
- A child has an additional anomaly or disability that may affect to his/her functional or neurological development
- Inner ear anomaly
- Mother's pregnancy duration less than 32 weeks
Sites / Locations
- Department of Otorhinolaryngology, Helsinki University Hospital
- Department of Otorhinolaryngology, Kuopio University Hospital
- Department of Otorhinolaryngology, Oulu University Hospital
- Tampere University Hospital
- Department of Otorhinolaryngology, Turku University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
bilateral cochlear implant
cochlear implant and hearing aid
bilateral hearing aid
Arm Description
Outcomes
Primary Outcome Measures
Assessment of auditory performance skills of bilaterally or bimodally implanted children or children with bilateral hearing aids
Secondary Outcome Measures
To compare post-operative speech perception ability, language acquisition, and speech production
To compare speech recognition performance
Quality of life and functional communicative performance assessed by parental proxy measures, and health economical assessment
To evaluate operative and post-operative complications, side-effects and device failures
To evaluate the differences in balance function
Full Information
NCT ID
NCT00960102
First Posted
August 14, 2009
Last Updated
August 16, 2022
Sponsor
Kuopio University Hospital
Collaborators
University of Eastern Finland, Hospital District of Helsinki and Uusimaa, University of Helsinki, Oulu University Hospital, University of Oulu, Turku University Hospital, Tampere University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00960102
Brief Title
Children's Bilateral Cochlear Implantation in Finland
Acronym
FinBiCI
Official Title
Children's Bilateral Cochlear Implantation in Finland: a Prospective, Controlled, Multicenter Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2009 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital
Collaborators
University of Eastern Finland, Hospital District of Helsinki and Uusimaa, University of Helsinki, Oulu University Hospital, University of Oulu, Turku University Hospital, Tampere University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deafness, Hearing Loss
Keywords
cochlear implantation, hearing aid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bilateral cochlear implant
Arm Type
Active Comparator
Arm Title
cochlear implant and hearing aid
Arm Type
Active Comparator
Arm Title
bilateral hearing aid
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
cochlear implant
Intervention Description
Multichannel Nucleus cochlear implant
Intervention Type
Device
Intervention Name(s)
hearing aid
Intervention Description
Phonak hearing aid
Primary Outcome Measure Information:
Title
Assessment of auditory performance skills of bilaterally or bimodally implanted children or children with bilateral hearing aids
Time Frame
Various time points up to 5 years hearing age
Secondary Outcome Measure Information:
Title
To compare post-operative speech perception ability, language acquisition, and speech production
Time Frame
Various time points up to 5 years hearing age
Title
To compare speech recognition performance
Time Frame
Various time points up to 5 years hearing age
Title
Quality of life and functional communicative performance assessed by parental proxy measures, and health economical assessment
Time Frame
Various time points up to 5 years hearing age
Title
To evaluate operative and post-operative complications, side-effects and device failures
Time Frame
Various time points up to 5 years hearing age
Title
To evaluate the differences in balance function
Time Frame
at 3 and 5 year age
10. Eligibility
Sex
All
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Congenital severe or profound bilateral hearing impairment
No functional benefit from conventional hearing aids (minimum 3 months trial)
Radiologically (CT,MRI) patent inner ears and normal central auditory pathways
Family is motivated for rehabilitation programme and gives a written consent
Finnish or Swedish as the primary language in the home
Exclusion Criteria:
A child has an additional anomaly or disability that may affect to his/her functional or neurological development
Inner ear anomaly
Mother's pregnancy duration less than 32 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heikki J Löppönen, M.D.,Prof.
Organizational Affiliation
Department of Otorhinolaryngology, Institute of Clinical Medicine, Kuopio University and Kuopio University Hospital, Finland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Taina T Välimaa, Ph.D.
Organizational Affiliation
Faculty of Humanities, Logopedics, University of Oulu, Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Otorhinolaryngology, Helsinki University Hospital
City
Helsinki
Country
Finland
Facility Name
Department of Otorhinolaryngology, Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70211
Country
Finland
Facility Name
Department of Otorhinolaryngology, Oulu University Hospital
City
Oulu
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Facility Name
Department of Otorhinolaryngology, Turku University Hospital
City
Turku
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
34260435
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.
Results Reference
derived
Learn more about this trial
Children's Bilateral Cochlear Implantation in Finland
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