RecruitingOBSERVATIONAL

Cross-sectional and Prospective Study to Characterize Early-onset Presbycusis

This research study is for people who start to notice hearing loss in both ears during adulthood. The main goal is to understand more about this kind of hearing loss, especially when it's caused by a change in a gene called GJB2. Researchers want to learn how it develops and changes over time for these individuals. They hope to get a clearer picture of how this genetic factor affects adult-onset hearing loss. By studying participants who have this specific genetic change, they aim to gather important information that could help in the future understanding and management of hearing problems linked to genetics.

At a glance

Status

Recruiting

Sponsor

Sensorion

Enrolment target

100

Start

14 Jun 2024

Estimated completion

01 Jul 2027

Sensorineural Hearing Loss, Bilateral

What is this study about?

Imagine your hearing starting to change as you get older, not from loud noises or an illness, but possibly because of your genes. This research study is trying to understand more about a specific type of hearing loss that begins in adulthood, affects both ears, and is called 'sensorineural hearing loss'. The scientists leading this study are particularly interested in people who have a genetic change, or 'mutation', in a gene known as GJB2. This gene is important for healthy hearing.

The main idea behind this study is to paint a clearer picture of how this type of hearing loss develops. They want to see how it might change over time for people with this specific genetic factor. By carefully observing a group of people, the researchers hope to learn more about the early signs, how it progresses, and what might influence its development. This knowledge could be really helpful in the future for understanding similar types of hearing loss.

Taking part would involve some initial checks to see if you have this specific gene change. If you do, you would then be invited to be followed over a period of time. This isn't about testing new treatments, but rather about gathering important information to better understand the condition itself. The more we understand, the better equipped medical professionals will be to help people with similar hearing challenges in the future.

Key takeaways

Study focused on adult-onset, bilateral hearing loss.
Specifically looking at people with GJB2 gene changes.
Aims to understand how this hearing loss develops over time.
Involves hearing tests and genetic checks.
No new treatments, purely observational research.
Helps advance understanding for future care.

Who may be eligible?

This study is looking for men and women between 30 and 55 years old. To be considered, you must have noticed hearing loss in both ears after you turned 16. A key part of joining is having already had a genetic test that shows you have specific changes in your GJB2 gene. This genetic link is what the study is focusing on.

However, not everyone can join. If your hearing loss is known to be caused by something other than genetics – for example, if it's due to an injury or a specific illness – then this study wouldn't be suitable for you. Also, if the researchers feel you might not be able to follow the study's instructions or attend appointments for any reason, you wouldn't be able to take part.

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.

Are you between 30 and 55 years old?
Did you first notice hearing loss in both ears after age 16?
Have you had a genetic test showing a change in your GJB2 gene?
Is your hearing loss NOT due to a known non-genetic cause?
Are you able and willing to attend study appointments?

Answer every question to see your result.

What does participation involve?

If you join this study, your involvement would begin with some initial assessments. These would likely include detailed hearing tests, also known as audiological assessments, to measure your hearing abilities. You would also have blood or saliva samples taken for genetic testing if you haven't already had this done, or to confirm existing results. If you are found to have the specific GJB2 gene changes the study is looking for, you would then be asked to continue in a follow-up period.

During this follow-up, you would have regular check-ups, which would involve more hearing tests. The aim is to see how your hearing changes over time. There are no new medications or experimental treatments involved; this is purely an observational study. The total duration of your participation, including follow-up, would be discussed with you by the research team, but it's designed to track changes over a sustained period.

Potential risks and benefits

A potential benefit of taking part is contributing valuable information that could help future understanding of adult-onset hearing loss, especially that linked to genetics. You might also gain a more detailed understanding of your own hearing condition through the assessments. Potential risks are generally low, mainly related to the minor discomfort of blood sampling if required. There are no direct medical risks as this study does not involve new drugs or procedures. You are free to withdraw from the study at any time and for any reason, without it affecting your medical care.

Locations (2)

The University of South Florida Board of Trustees
Verified postcode
Tampa, United States· Recruiting
CHU Gui de Chauliac
Verified postcode
Montpellier, France· Recruiting

Common questions

What is GJB2 gene?

The GJB2 gene provides instructions for making a protein that's important for healthy hearing in your inner ear. Changes in this gene can sometimes lead to hearing loss.

Will I receive treatment if I join?

No, this study is about understanding hearing loss, not providing treatment. You will continue to receive care from your usual doctors.

How often would I need to visit the clinic?

If you qualify, you would have an initial visit, and then follow-up visits would be scheduled. The team will tell you the exact schedule.

Do I have to pay to join the study?

No, you will not have to pay to participate in this research study.

What kind of hearing loss is this study looking at?

It's looking at 'sensorineural' hearing loss that affects both ears and starts in adulthood, especially when it's linked to a change in the GJB2 gene.

How to find out more

Lionel HOVSEPIAN, MD

lionel.hovsepian@sensorion-pharma.com +33786311376 Official trial record

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