RecruitingOBSERVATIONAL

Analysis of Parental Support in Families Using the LENA After Early Cochlear Implantation

This study explores how helping parents can boost speech development in young children who are deaf and have received a cochlear implant. We focus on babies implanted before 18 months of age. A special device called LENA (Language ENvironment Analysis) is used to record the sounds and conversations a child hears and makes at home. This helps us understand their language environment. We then provide parents with feedback from these recordings to help them create the best possible conditions for their child's speech to grow. The goal is to see if this parental support, based on the LENA data, makes a real difference in how well these children learn to speak.

At a glance

Status

Recruiting

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

Start

13 Sep 2024

Estimated completion

01 Jul 2026

Profound Congenital Deafness Cochlear Implantation

What is this study about?

When children are born with profound deafness and receive a cochlear implant early on, it's a big step towards helping them hear and learn to speak. However, how well they develop their language skills isn't just about the implant itself. It also depends a lot on the sounds and language they are surrounded by in their first few months and years. Parents play a hugely important role in creating this language-rich environment for their child.

This study is looking at a new way to support parents in this journey. We use a clever tool called LENA, which stands for Language ENvironment Analysis. Imagine a small device that a child wears for part of the day at home. It records sounds and conversations, but without identifying specific speech. Instead, it measures things like how many words adults say around the child, how many words the child tries to say, and how much background noise or electronic media they are exposed to.

The idea is that by understanding this 'language environment' in a detailed and objective way, we can give parents really tailored advice and support. The study will provide families with information from these LENA recordings. Then, a speech therapist will work with them to use this information to create even better opportunities for their child to hear and use language. We want to see if this method of giving parents specific feedback helps children learn to speak more effectively after their cochlear implant.

Key takeaways

The study helps deaf children learn to speak after cochlear implant surgery.
It uses a special LENA device to understand a child's home language environment.
Parents receive tailored feedback to improve their child's language development.
Participation involves two days of recording at home, several months apart.
The study focuses on children implanted before 18 months of age.

Who may be eligible?

This study is looking for very young children who were born with severe deafness and have recently had a cochlear implant. To join, children must have received their implant when they were between 8 and 18 months old, and they need to have been using it for at least three months. They should also be between 11 and 21 months old when they start the study. It's important that they wear their implant consistently every day and are already receiving speech therapy.

Familiar children and families must speak French. Both parents or guardians need to agree for their child to take part. Unfortunately, some children won't be able to join. This includes children who have certain other health conditions that might greatly affect their language development, such as specific genetic syndromes, or other major health issues like autism or serious vision problems that aren't corrected. If the child doesn't wear their implant every day, they also wouldn't be suitable for this study.

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 profoundly deaf and has had a cochlear implant?
Was your child implanted between 8 and 18 months old?
Is your child currently between 11 and 21 months old?
Does your child wear their implant every day and receive speech therapy?
Do you speak French as a parent?

Answer every question to see your result.

What does participation involve?

If your child takes part, they will wear a small LENA recording device for 10-16 hours at home on two separate occasions, about six months apart. This device will simply record sounds in their environment. After each recording period, the study team will analyse the data collected by the LENA device using special software. You will then receive feedback on your child's language environment from a speech therapist, based on these recordings. The total duration of your participation in the study, including the two recording periods and feedback sessions, will be over several months.

Potential risks and benefits

Participating in this study might offer you and your child a better understanding of their language environment and tailored support from a speech therapist, which could help boost their speech development. The LENA device is a listening tool and does not pose physical risks. There are no known risks involved beyond the time commitment. You are free to withdraw your child from the study at any time, for any reason, without it affecting your child’s standard of care.

Locations (1)

Hôpital Necker-Enfants Malades
Verified postcode
Paris, France· Recruiting

Common questions

What is a cochlear implant?

A cochlear implant is a small electronic device that helps profoundly deaf people to hear. It's different from a hearing aid, as it's surgically placed inside the ear and works by directly stimulating the hearing nerve.

What does the LENA tool do?

The LENA tool is a small recorder that your child wears. It records sounds throughout the day to measure how much language they hear and use, as well as background noise, without recording specific words.

Will the study tell me exactly what my child is saying?

No, the LENA tool does not record specific words or conversations. It focuses on general patterns like how many words adults say around the child, how many sounds the child makes, and how often they engage in 'conversational turns' with an adult.

How long will my child need to wear the LENA device?

Your child will wear the LENA device for 10-16 hours on two separate days, about six months apart, during their usual home activities.

Will this study affect my child's regular speech therapy?

No, this study aims to complement and support your child's existing speech therapy by providing you and your therapist with more detailed information about their home language environment.

How to find out more

Clara LEGENDRE, speech therapist

clara.legendre@aphp.fr 1 71 39 67 96 Official trial record

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