Clinical trial NCT06841900: Implementation of the International Classification of Functioning, Disability and Health Model in Paediatric Cochlear Implant Recipients
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cochlear Impant Children
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Paediatric Cochlear Implant (CI) recipients (\<18 years) with prelingual sensorineural hearing loss

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.


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

Primary outcomes:
measure: Change in LittlEARS® Auditory Questionnaire (LEAQ)
timeFrame: 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor
measure: Change in Speech, Spatial and Qualities of Hearing Scale for Parents (SSQ-P)
timeFrame: 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor
measure: Change in Speech Intelligibility Rating (SIR)
timeFrame: 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor
measure: Parent's Evaluation of Aural/Oral Performance of Children (PEACH)
timeFrame: 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor
measure: Standard pure tone audiometry, Behavioral Observation Audiometry (BOA), Visual Reinforcement Audiometry (VRA) or Play Audiometry
timeFrame: 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor
measure: Auditory Brainstem Response (ABR) Audiometry
timeFrame: 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor
measure: Ling Sounds (detection/discrimination)
timeFrame: 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor
Secondary outcomes:
measure: Subject Demographics
timeFrame: 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Fiona Stanley Fremantle Hospital Group
city: Edegem
country: Belgium
facility: University Hospital Antwerp
city: Würzburg
country: Germany
facility: University Clinic of Würzburg
city: Warsaw
country: Poland
facility: World Hearing Centre
city: Riyadh
country: Saudi Arabia
facility: King Abdullah Ear Specialist Center (KAESC)
city: Madrid
country: Spain
facility: Hospital La Paz
Study officials:
References: