Language: BG BG
← Back to results
Not yet recruiting NCT06841900

Implementation of the International Classification of Functioning, Disability and Health Model in Paediatric Cochlear Implant Recipients

Conditions: Cochlear Impant Children

Sponsor: University Hospital, Antwerp

trial.available_in: БГ
Overview
The aim of this study is to implement the International Classification of Functioning, disability and health (ICF) in paediatric Cochlear Implant (CI) recipients (\<18 years) with prelingual sensorineural hearing loss in a multicenter prospective study to evaluate audiological rehabilitation after cochlear implantation. For this, ICF qualifiers which denote the magnitude of the level of health or severity of the problem will be quantified. Outcome measures include four questionnaires and three standard audiological examinations. Subjects will be assessed up to 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor.
Who can participate
Inclusion Criteria: General * 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: General * 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
Locations 6
Australia (1)
Fiona Stanley Fremantle Hospital Group
Perth
Belgium (1)
University Hospital Antwerp
Edegem
Germany (1)
University Clinic of Würzburg
Würzburg
Poland (1)
World Hearing Centre
Warsaw
Saudi Arabia (1)
King Abdullah Ear Specialist Center (KAESC)
Riyadh
Spain (1)
Hospital La Paz
Madrid
Technical details
Status
Not yet recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Healthy volunteers
No
Start date
01.03.2025
Completion date
01.03.2027
Registry ID
NCT06841900
Source
anzctr
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.