Speech-Evoked Auditory Potentials: Multisite Pediatric Evaluation
This research is testing a brand-new device that measures how a baby's brain reacts to speech sounds. We are looking at infants between 3 and 24 months old, including those with normal hearing and those with hearing loss who use hearing aids. The main goals are to find out if this device can accurately show differences in brain responses between these groups, and particularly how hearing aids might change these brain reactions. This could help improve how we understand and support babies with hearing difficulties in the future. The study involves measuring brain responses over one or two short sessions.
At a glance
What is this study about?
This study, called "Speech-Evoked Auditory Potentials: Multisite Pediatric Evaluation," is exploring a new way to understand how babies' brains process speech. Researchers are using a special prototype device to measure brain responses to speech sounds. Think of it like seeing how the brain 'lights up' or reacts when it hears someone speaking, but without needing the baby to actively respond.
The main aim is to see if this new device can accurately detect brain activity in infants, especially those with hearing loss. They want to compare the brain responses of babies with normal hearing to those with hearing loss, and also see if there's a difference when babies with hearing loss are wearing their hearing aids versus when they are not. This information could be really helpful for developing better ways to assess and support children with hearing difficulties.
This research is a team effort, involving groups like the National Acoustic Laboratories (NAL) in Australia and Audioscan, a Canadian company that developed the prototype device. It's an important step in making sure new medical devices are safe and effective, and it’s approved by Health Canada for this testing.
Key takeaways
- Testing a new device to measure babies' brain responses to speech.
- Includes babies aged 3-24 months, with and without hearing loss.
- Aims to see how hearing aids affect brain reactions to speech sounds.
- Non-invasive measurements over 1-2 short sessions.
- Results could help improve hearing support for infants.
- Participants can leave the study at any time.
Who may be eligible?
To be considered for this study, your baby needs to be an infant between 3 and 24 months old.
Your baby can participate if they have normal hearing and have already had a doctor confirm this through their hearing checks. Also, infants with hearing loss can join if their parents have chosen for them to use spoken language to communicate, and if they have already been given and are using hearing aids.
However, your baby cannot take part if they have problems with their middle ear (like certain ear infections) or if they have a lot of ear wax blocking their ear canal.
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 baby between 3 and 24 months old?
- Does your baby have normal hearing (confirmed by a doctor)?
- If your baby has hearing loss, have you chosen spoken language for them, and do they use hearing aids?
- Does your baby have any middle ear problems or excessive ear wax?
- Is your family located near one of the study locations (like Australia or potentially others listed in the clinical trial details)?
What does participation involve?
If your baby takes part, they will have their brain responses measured using the new prototype device. This is a non-invasive process, meaning nothing goes inside their body. They will listen to simple, average-level speech-like sounds. This measurement will happen over one or possibly two appointments. If your baby has hearing loss and uses hearing aids, there will be one session where they wear their hearing aids and another where they don't. Each session doesn't last very long. There are no medications involved in this study, and no long-term follow-up beyond the short study period.
Potential risks and benefits
Locations (3)
- National Acoustic LaborartoryVerified postcodeMacquarie Park, Australia
- Dalhousie UniversityVerified postcodeHalifax, Canada
- National Centre for Audiology at Western UniversityVerified postcodeLondon, Canada
Common questions
What is a 'prototype device'?
A prototype device is an early version of a new piece of equipment that is being tested to see how well it works before it's made widely available.
Will my baby feel anything during the brain response measurements?
No, your baby won't feel anything. The device measures brain activity without touching or harming them, similar to how an EEG works to read brain waves.
Is this device approved for general use?
No, this device is still a prototype and is not yet approved for general use. The study is part of the process to test it and eventually gain approval.
How long will each study session take?
The study description doesn't give exact times, but it mentions 1 to 2 sessions in total, suggesting they are not long and are manageable for infants.
Does my baby need to speak to participate?
No, your baby does not need to speak. The study measures brain responses to sounds, not their ability to talk. For babies with hearing loss, it's about whether parents chose for them to use spoken language as their main form of communication.
How to find out more
Susan Scollie, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.