Not yet recruitingOBSERVATIONAL

Impact of Vestibular Function on Deaf Infants' Activities of Daily Living

This study wants to understand how problems with balance and movement (called vestibular impairment) might affect deaf children under two years old. We know that some deaf children also have issues with their balance, which can make everyday activities harder. The study will look at three groups: deaf children with balance issues, deaf children without balance issues, and hearing children without any balance problems. Parents will answer questions about their child's daily activities, like personal care, playing, and socialising. We will also talk to some parents about their experiences. This information will help doctors understand what these children need and how to support them better from a young age.

At a glance

Status

Not yet recruiting

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

105

Start

27 Mar 2025

Estimated completion

01 Apr 2028

Vestibular Dysfunction Hearing Loss Motor Development

What is this study about?

This research is looking into how balance problems can affect very young deaf children, specifically those aged up to two years old. Everyone uses their 'vestibular system' (which is part of the inner ear) for balance, posture, and knowing where their body is in space. If this system isn't working properly, it can make everyday things like sitting up, walking, or even playing a bit harder. This study wants to see how these balance issues might impact a deaf child's ability to do daily tasks.

To do this, the study will involve three different groups of children. There will be deaf children who have problems with their balance, deaf children who don't have balance problems, and a third group of hearing children who also don't have balance problems. By comparing these groups, the researchers hope to understand more clearly if balance difficulties specifically affect deaf children's daily lives more than just being deaf alone or being a hearing child. They are especially interested in tasks like getting dressed, playing with toys, and interacting with others.

The main aim of this study is to gather information that can help improve support for deaf children, especially those with balance issues. By learning more about their challenges early on, doctors and therapists can develop better ways to help these children develop their skills and manage everyday activities as they grow up. The study is taking place at the Robert Debré Hospital in Paris, and they aim to include 105 children over three years. This kind of research is really important for making sure every child gets the right help at the right time.

Key takeaways

The study explores how balance problems affect deaf children aged 0-2 years.
It involves filling out questionnaires about your child's daily activities.
No new treatments or medicines are given; it's purely observational.
Compares deaf children with/without balance issues and hearing children.
Aims to improve early support and interventions for these children.

Who may be eligible?

This study is looking for children aged from birth up to two years old. They need three different types of children to take part. The first group includes deaf children who also have known balance problems. The second group is for deaf children who do not have any balance problems that have been identified. The third group is for hearing children who also do not have balance problems; this group helps the researchers compare the other two groups to children who don't have hearing or balance challenges.

Your child won't be able to join if they have certain other health issues. For example, if they have problems with their muscles, bones, or nervous system that might affect their movement. Also, if they have certain developmental conditions that could make it harder to assess their daily activities, they wouldn't be able to take part. The study is open to both boys and girls.

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 my child between birth and two years old?
Is my child deaf AND has balance problems?
OR is my child deaf but does NOT have balance problems?
OR is my child hearing and does NOT have balance problems?
Does my child NOT have any muscle, bone, or nerve conditions?
Does my child NOT have any major developmental conditions that would affect assessing daily activities?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, you won't need to visit a special research clinic just for the study. Instead, the study activities will be woven into your child's regular appointments at the ENT (Ear, Nose, and Throat) department. There aren't any new medicines or treatments involved, as this is an observational study, meaning the researchers are just watching and learning.

The main part of your child's involvement will be an assessment using a questionnaire called 'OT Hope 0-5 years'. This questionnaire is filled in by you, the parents, and helps measure your child's abilities in daily tasks like personal care, playing, and socialising. An occupational therapist will be there to help you complete it. Some parents may also be asked if they'd like to take part in an interview. This interview would be a chance for you to talk about your experiences, challenges, and strategies for your child's daily routines and movement development. The total duration of your child's participation will depend on how many regular appointments they have during the three-year study period.

Potential risks and benefits

Participating in this study involves very few risks, as it only includes filling out questionnaires and optional interviews during your child's routine hospital visits. There are no medical procedures or new treatments. A potential benefit is that the information gathered will help doctors and therapists better understand the specific needs of deaf children with balance issues, which could lead to improved support and early interventions in the future. You are completely free to decide if you want your child to take part, and you can withdraw from the study at any time without giving a reason, and this will not affect your child's medical care.

Locations (1)

Robert Debré Hospital
Verified postcode
Paris, France

Common questions

What does 'vestibular impairment' mean?

It means your child has problems with their inner ear system that helps with balance and knowing where their body is in space.

Will my child receive any new treatments in this study?

No, this is an 'observational' study, meaning researchers are just gathering information, not testing new treatments or medicines.

How long will my child be involved in the study?

Participation will happen during your child's routine hospital appointments, and the study aims to enrol children over a three-year period. Your personal involvement duration might be shorter based on your child's appointments.

Will I have to pay for anything if my child participates?

No, there are no costs for you or your child to take part in this research study.

Will our family's information be kept private?

Yes, all data collected will be handled confidentially and used according to strict privacy rules.

How to find out more

Audrey MAUDOUX, MD

audrey.maudoux@aphp.fr +33140032449 Official trial record

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