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Children's Bilateral Cochlear Implantation in Finland (FinBiCI)

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ClinicalTrials.gov Identifier: NCT00960102
Recruitment Status : Unknown
Verified August 2015 by Heikki Lopponen, Kuopio University Hospital.
Recruitment status was:  Recruiting
First Posted : August 17, 2009
Last Update Posted : August 7, 2015
Sponsor:
Collaborators:
University of Eastern Finland
Hospital District of Helsinki and Uusimaa
Helsinki University
Oulu University Hospital
University of Oulu
Turku University Hospital
Tampere University Hospital
Information provided by (Responsible Party):
Heikki Lopponen, Kuopio University Hospital

August 14, 2009
August 17, 2009
August 7, 2015
August 2009
December 2015   (Final data collection date for primary outcome measure)
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 ]
Assessment of auditory performance skills of bilaterally or unilaterally implanted children [ Time Frame: Various time points up to 5 years hearing age ]
Complete list of historical versions of study NCT00960102 on ClinicalTrials.gov Archive Site
  • To compare post-operative speech perception ability, language acquisition, and speech production [ Time Frame: 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 ]
  • 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 ]
  • To evaluate operative and post-operative complications, side-effects and device failures [ Time Frame: Various time points up to 5 years hearing age ]
  • To evaluate the differences in balance function [ Time Frame: at 3 and 5 year age ]
  • To compare post-operative speech perception ability, language acquisition, and speech production over time between children with bilateral cochlear implants and children with unilateral cochlear implant and hearing aid [ Time Frame: Various time points up to 5 years hearing age ]
  • To compare speech recognition performance of bilaterally implanted subjects to unilaterally implanted subjects [ Time Frame: 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 ]
  • To evaluate operative and post-operative complications, side-effects and device failures [ Time Frame: Various time points up to 5 years hearing age ]
  • To evaluate the differences in balance function between children with bilateral cochlear implant surgery compared to children with unilateral cochlear implant surgery [ Time Frame: at 3 and 5 year age ]
Not Provided
Not Provided
 
Children's Bilateral Cochlear Implantation in Finland
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 in Finnish children.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Deafness
  • Hearing Loss
  • Device: cochlear implant
    Multichannel Nucleus cochlear implant
  • Device: hearing aid
    Phonak Valeo hearing aid
  • Active Comparator: bilateral cochlear implant
    Intervention: Device: cochlear implant
  • Active Comparator: cochlear implant and hearing aid
    Interventions:
    • Device: cochlear implant
    • Device: hearing aid
  • Active Comparator: bilateral hearing aid
    Intervention: Device: hearing aid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
40
Same as current
December 2017
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 24 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
 
NCT00960102
KUH5551819
No
Not Provided
Not Provided
Heikki Lopponen, Kuopio University Hospital
Kuopio University Hospital
  • University of Eastern Finland
  • Hospital District of Helsinki and Uusimaa
  • Helsinki University
  • Oulu University Hospital
  • University of Oulu
  • Turku University Hospital
  • Tampere University Hospital
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
Kuopio University Hospital
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP