Implementation of the International Classification of Functioning, Disability and Health Model in Paediatric Cochlear Implant Recipients
NCT ID: NCT06841900
Last Updated: 2025-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
120 participants
OBSERVATIONAL
2025-03-31
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cochlear Implant (CI) recipients (<18 years) with prelingual sensorineural hearing loss
Cochlear Implant (CI) recipients (\<18 years) with prelingual sensorineural hearing loss
Cochlear Implantation
Standard cochlear implantation
Interventions
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Cochlear Implantation
Standard cochlear implantation
Eligibility Criteria
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Inclusion Criteria
* Children aged \< 18 years with prelingual bilateral severe-to-profound HL
* Signed and dated informed consent, informed permission and/or minor's assent.
* Willingness to participate in evaluations, test sessions, and medical follow-up sessions as defined in the protocol.
* Physical and mental competence to participate in fitting of the device and follow-up sessions as defined in the protocol.
Audiological
* Completion of hearing assessment battery showing suitability of the CI candidates.
* Compliance with cochlear implant candidate selection criteria of the implanting centre.
* First cochlear implantation Medical
* Patent cochlea, as evidenced by High-resolution computed tomography (HRCT) and/or Magnetic Resonance Imaging (MRI).
Exclusion Criteria
* Re-implantation of the cochlear implant
* No motivation to participate in the study and/or unreasonable expectations. Medical
* Presence of contra-indications for surgery in general and cochlear implantation in particular.
* Presence of central auditory lesions.
* Any disorder that may relate to an increased risk of skin flap problems Use of one of the following electrodes for implantation
* Compressed
* Split
* Any type of custom made electrodes
ALL
No
Sponsors
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University Hospital, Antwerp
OTHER
Responsible Party
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Locations
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Fiona Stanley Fremantle Hospital Group
Perth, , Australia
University Hospital Antwerp
Edegem, , Belgium
University Clinic of Würzburg
Würzburg, , Germany
World Hearing Centre
Warsaw, , Poland
King Abdullah Ear Specialist Center (KAESC)
Riyadh, , Saudi Arabia
Hospital La Paz
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ICF in Paediatric CI users
Identifier Type: -
Identifier Source: org_study_id
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