Not Yet RecruitingNot Applicable

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

Australia, Belgium, Germany120 participantsStarted 2025-03

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

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

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

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

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

Trial details

NCT IDNCT06841900

SponsorUniversity Hospital, Antwerp

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-03

Contact for this trial

Ellen Andries, PhD AUD

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

View on ClinicalTrials.gov More Cochlear Impant Children trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

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

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

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

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

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