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ClinicalTrials.gov ID

NCT06841900

Lead Sponsor

University Hospital, AntwerpOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

120Estimated

Last Update Posted

Feb 28, 2025Actual

Start Date

Mar 2025Estimated

Primary Completion Date

Mar 2027Estimated

Completion Date

Mar 2027Estimated

Official Title

Implementation of the International Classification of Functioning, Disability and Health Model in Paediatric Cochlear Implant Recipients: a Multi-center Prospective Follow-up Cohort Study

Brief Summary

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.

• Cochlear Impant Children

• Cochlear Implantation

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

University Hospital, AntwerpOTHER

ellen.andries@uza.be+32 3 275 7372

Kurz_A@ukw.de+49 - 931 201 21701

a.lorens@ifps.org.pl954-404-6477

miryamcf@yahoo.com+34 917 27 70 00