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Children's Bilateral Cochlear Implantation in Finland (FinBiCI)

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ClinicalTrials.gov Identifier: NCT00960102
Recruitment Status : Completed
First Posted : August 17, 2009
Last Update Posted : August 9, 2018
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

Brief Summary:
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 or disease Intervention/treatment Phase
Deafness Hearing Loss Device: cochlear implant Device: hearing aid Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Children's Bilateral Cochlear Implantation in Finland: a Prospective, Controlled, Multicenter Study
Study Start Date : August 2009
Actual Primary Completion Date : August 7, 2018
Actual Study Completion Date : August 7, 2018

Resource links provided by the National Library of Medicine


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 Valeo hearing aid

Active Comparator: bilateral hearing aid Device: hearing aid
Phonak Valeo hearing aid




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


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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00960102


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

Responsible Party: Heikki Lopponen, M.D.,Prof., Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00960102     History of Changes
Other Study ID Numbers: KUH5551819
First Posted: August 17, 2009    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018

Keywords provided by Heikki Lopponen, Kuopio University Hospital:
cochlear implantation

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