Children's Bilateral Cochlear Implantation in Finland (FinBiCI)

August 16, 2022 updated by: Heikki Lopponen, Kuopio University Hospital

Children's Bilateral Cochlear Implantation in Finland: a Prospective, Controlled, Multicenter Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • Department of Otorhinolaryngology, Helsinki University Hospital
      • Kuopio, Finland, 70211
        • Department of Otorhinolaryngology, Kuopio University Hospital
      • Oulu, Finland
        • Department of Otorhinolaryngology, Oulu University Hospital
      • Tampere, Finland
        • Tampere University Hospital
      • Turku, Finland
        • Department of Otorhinolaryngology, Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: bilateral cochlear implant
Device: cochlear implant
Multichannel Nucleus cochlear implant
ACTIVE_COMPARATOR: cochlear implant and hearing aid
Device: cochlear implant
Multichannel Nucleus cochlear implant
Device: hearing aid
Phonak hearing aid
ACTIVE_COMPARATOR: bilateral hearing aid
Device: hearing aid
Phonak hearing aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Various time points up to 5 years hearing age

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare post-operative speech perception ability, language acquisition, and speech production
Time Frame: Various time points up to 5 years hearing age
Various time points up to 5 years hearing age
To compare speech recognition performance
Time Frame: Various time points up to 5 years hearing age
Various time points up to 5 years hearing age
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
Various time points up to 5 years hearing age
To evaluate operative and post-operative complications, side-effects and device failures
Time Frame: Various time points up to 5 years hearing age
Various time points up to 5 years hearing age
To evaluate the differences in balance function
Time Frame: at 3 and 5 year age
at 3 and 5 year age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuopio University Hospital

Collaborators

Turku University Hospital
Oulu University Hospital
University of Helsinki
University of Eastern Finland
Tampere University Hospital
University of Oulu
Hospital District of Helsinki and Uusimaa

Investigators

  • Study Director: Heikki J Löppönen, M.D.,Prof., Department of Otorhinolaryngology, Institute of Clinical Medicine, Kuopio University and Kuopio University Hospital, Finland
  • Principal Investigator: Taina T Välimaa, Ph.D., Faculty of Humanities, Logopedics, University of Oulu, Finland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2009

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

August 14, 2009

First Submitted That Met QC Criteria

August 14, 2009

First Posted (ESTIMATE)

August 17, 2009

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH5551819

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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