Not yet recruitingOBSERVATIONAL

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

This study is for children under 18 who have severe hearing loss from birth and are getting a cochlear implant for the first time. Researchers want to understand how the implant helps these children in their daily lives. They will use a special checklist, called the International Classification of Functioning, Disability and Health (ICF), to look at various aspects of the children's health, activities, and participation in their community. The study involves several check-ups and simple hearing tests before the implant and at 3 months, 6 months, and 1 year after the sound processor is turned on, to see how they are progressing. The goal is to get a clearer picture of how cochlear implants improve the lives of young children.

At a glance

Status

Not yet recruiting

Sponsor

University Hospital, Antwerp

Enrolment target

120

Start

01 Mar 2025

Estimated completion

01 Mar 2027

Cochlear Impant Children

What is this study about?

This research wants to understand how children under 18, who were born with severe hearing loss, adapt and improve after they receive a cochlear implant. A cochlear implant is a small electronic device that helps people with severe hearing loss to hear. It's different from a hearing aid, which just makes sounds louder. This study focuses on children who get the implant in one or both ears for the very first time.

The main aim is to use a special tool called the International Classification of Functioning, Disability and Health (ICF). Think of the ICF as a detailed checklist that helps doctors and researchers understand a person's health beyond just their medical condition. It looks at how the hearing loss and the implant affect a child's body functions (like hearing itself), their daily activities (like talking or playing), and their participation in life (like going to school or interacting with friends). By using this tool, the researchers hope to get a full picture of how the implant helps children in different areas of their lives.

This study is important because it will give doctors and families more information about what to expect after a child receives a cochlear implant. It will help them understand the benefits and improvements in a child's hearing, communication, and overall quality of life. This knowledge can then be used to provide even better care and support for children who get cochlear implants in the future.

Key takeaways

This study helps understand how cochlear implants improve children's lives.
It's for children under 18 with severe hearing loss getting an implant for the first time.
Participation involves a few check-ups and simple hearing tests over a year.
No extra medications are given as part of the study.
Results could help improve care for children with cochlear implants in the future.

Who may be eligible?

This study is looking for children under the age of 18 who were born with very severe hearing loss in both ears. They should be getting a cochlear implant for the very first time. Before joining, their doctors need to confirm that a cochlear implant is a suitable option for them, and the child's inner ear (cochlea) needs to be in good condition, usually checked with scans like MRI.

To take part, the child and their parents or guardians must be willing to attend all the study appointments and tests. This means understanding and agreeing to what the study involves. It's also important that the child is able to cope with the process of getting the device adjusted and having follow-up appointments.

Children would not be able to join if they have already had a cochlear implant and are getting a new one, or if they have certain other health problems that might make the surgery risky or affect their ability to use the implant properly. People who show they are not motivated to participate or have unrealistic expectations about the outcome would also not be included.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child under 18 years old?
Was your child born with severe hearing loss in both ears?
Is your child expecting to get a cochlear implant for the first time?
Are you and your child willing and able to attend study appointments over about a year?
Has your child been medically approved for a cochlear implant?
Does your child NOT have other serious medical conditions that would make surgery risky or prevent them from using the implant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your child will have several appointments over about a year. Before the cochlear implant surgery, there will be an initial check-up and some hearing tests. Then, after your child's implant is switched on (this is called 'activation of the speech processor'), there will be follow-up appointments at 3 months, 6 months, and 1 year. During these visits, your child will complete four simple questionnaires and have three standard hearing tests to check their progress. There are no medications involved, just assessments to see how your child is doing with their new hearing.

Potential risks and benefits

Taking part in this study means you'll be helping doctors learn more about how cochlear implants improve children's lives. This could lead to better care for other children with hearing loss in the future. The assessments involve questionnaires and standard hearing tests, which are generally safe. However, as with any medical study, there's always a small chance of unforeseen issues, but these are kept to a minimum. You or your child can stop participating in the study at any time, for any reason, without it affecting your child's medical care.

Locations (6)

Fiona Stanley Fremantle Hospital Group
Verified postcode
Perth, Australia
University Hospital Antwerp
Verified postcode
Edegem, Belgium
University Clinic of Würzburg
Verified postcode
Würzburg, Germany
World Hearing Centre
Verified postcode
Warsaw, Poland
King Abdullah Ear Specialist Center (KAESC)
Verified postcode
Riyadh, Saudi Arabia
Hospital La Paz
Verified postcode
Madrid, Spain

Common questions

What is a cochlear implant?

A cochlear implant is a small electronic device that helps people with severe hearing loss to hear. It's surgically placed and helps to provide a sense of sound by sending signals directly to the hearing nerve.

What does 'prelingual sensorineural hearing loss' mean?

This means your child was born with hearing loss, or developed it before they learned to speak. 'Sensorineural' refers to the type of hearing loss, affecting the inner ear or the nerve to the brain.

What is the ICF checklist?

The ICF (International Classification of Functioning, Disability and Health) is a special tool used to understand how a health condition, like hearing loss, affects different parts of a person's life, including their body functions, daily activities, and participation in society.

Will my child have to take any extra medicines for this study?

No, this study does not involve any extra medicines. It focuses on using questionnaires and standard hearing tests.

How long will my child be in the study?

Your child will be followed for about one year after their cochlear implant's sound processor is switched on, with a few appointments during that time.

How to find out more

Ellen Andries, PhD AUD

ellen.andries@uza.be +32 3 275 7372 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.