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Trial record 1 of 1 for:    NCT00960102
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Children's Bilateral Cochlear Implantation in Finland (FinBiCI)

This study is currently recruiting participants.
Verified February 2013 by Kuopio University Hospital
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
ClinicalTrials.gov Identifier:
NCT00960102
First received: August 14, 2009
Last updated: February 15, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this study is to evaluate short and long term outcomes (benefits and side-effects) of bilateral cochlear implantation in Finnish children.


Condition Intervention Phase
Deafness
Hearing Loss
 Device: cochlear implant
Device: hearing aid
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Children's Bilateral Cochlear Implantation in Finland: a Prospective, Controlled, Multicenter Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • Assessment of auditory performance skills of bilaterally or unilaterally implanted children [ Time Frame: Various time points up to 5 years hearing age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To compare speech recognition performance of bilaterally implanted subjects to unilaterally implanted subjects [ Time Frame: Various time points up to 5 years hearing age ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate operative and post-operative complications, side-effects and device failures [ Time Frame: Various time points up to 5 years hearing age ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2009
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Valeo hearing aid

  Eligibility

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00960102

Contacts
Contact: Heikki J Löppönen, M.D.,Prof. +35817172508 heikki.lopponen@kuh.fi
Contact: Taina T Välimaa, Ph.D. +3588553 3396 taina.valimaa@oulu.fi

Locations
Finland
Department of Otorhinolaryngology, Helsinki University Hospital Recruiting
Helsinki, Finland
Contact: Antti Aarnisalo, M.D.         antti.aarnisalo@hus.fi    
Principal Investigator: Antti Aarnisalo, M.D.            
Department of Otorhinolaryngology, Kuopio University Hospital Recruiting
Kuopio, Finland, 70211
Contact: Antti Hyvärinen, M.D.     +35817173311     antti.hyvarinen@kuh.fi    
Principal Investigator: Antti Hyvärinen, M.D.            
Department of Otorhinolaryngology, Oulu University Hospital Recruiting
Oulu, Finland
Contact: Mirja Luotonen, M.D.         mirja.luotonen@ppshp.fi    
Principal Investigator: Mirja Luotonen, M.D.            
Tampere University Hospital Recruiting
Tampere, Finland
Contact: Juha-Pekka Vasama, M.D., Ph.D.         juha-pekka.vasama@pshp.fi    
Principal Investigator: Juha-Pekka Vasama, M.D.,Ph.D.            
Department of Otorhinolaryngology, Turku University Hospital Recruiting
Turku, Finland
Contact: Jaakko Salonen, M.D.         jakko.salonen@tyks.fi    
Principal Investigator: Jaakko Salonen, M.D.            
Sponsors and Collaborators
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
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
  More Information

No publications provided

Responsible Party: Heikki Lopponen, M.D.,Prof., Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00960102     History of Changes
Other Study ID Numbers: KUH5551819
Study First Received: August 14, 2009
Last Updated: February 15, 2013
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Kuopio University Hospital:
cochlear implantation

Additional relevant MeSH terms:
Deafness
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013