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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00960102
Other study ID # KUH5551819
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 2009
Est. completion date December 31, 2022

Study information

Verified date August 2022
Source Kuopio University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group N/A to 24 Months
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
cochlear implant
Multichannel Nucleus cochlear implant
hearing aid
Phonak hearing aid

Locations

Country Name City State
Finland Department of Otorhinolaryngology, Helsinki University Hospital Helsinki
Finland Department of Otorhinolaryngology, Kuopio University Hospital Kuopio
Finland Department of Otorhinolaryngology, Oulu University Hospital Oulu
Finland Tampere University Hospital Tampere
Finland Department of Otorhinolaryngology, Turku University Hospital Turku

Sponsors (8)

Lead Sponsor Collaborator
Kuopio University Hospital Hospital District of Helsinki and Uusimaa, Oulu University Hospital, Tampere University Hospital, Turku University Hospital, University of Eastern Finland, University of Helsinki, University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of auditory performance skills of bilaterally or bimodally implanted children or children with bilateral hearing aids Various time points up to 5 years hearing age
Secondary To compare post-operative speech perception ability, language acquisition, and speech production Various time points up to 5 years hearing age
Secondary To compare speech recognition performance Various time points up to 5 years hearing age
Secondary Quality of life and functional communicative performance assessed by parental proxy measures, and health economical assessment Various time points up to 5 years hearing age
Secondary To evaluate operative and post-operative complications, side-effects and device failures Various time points up to 5 years hearing age
Secondary To evaluate the differences in balance function at 3 and 5 year age
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