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โ† Trials
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Natural History in Children up to 16 Years With Mild to Profound Hearing Loss Due to Mutations in GJB2 / OTOF Genes

Recruitingn/aAges any - 16 YearsAllSensorion
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to follow the natural history of non-syndromic hearing loss caused by mutations in two genes (GJB2 or OTOF) in children up to 16 years of age.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Main Inclusion Criteria: Participants meeting all the following main inclusion criteria will be eligible to participate in the study: * Aged โ‰ค 16 years on the date of signed informed consent for cohort 1 and โ‰ค 10 years for cohort 2; * With a diagnosis of non-syndromic, bilateral, mild to profound, sensorineural hearing loss (according to the American Speech Language-Hearing Association); * With documented genotyping results showing mutation(s) in GJB2 or OTOF genes; * Written informed consent as required by local regulations. * Either without Cochlear Implant, or with unilateral or bilateral Cochlear Implant(s) Exclusion Criteria: Participants presenting with any of the following main exclusion criteria will not be included in the study * Other type of deafness, such as unilateral deafness, persistent conductive deafness, malformation syndrome, syndromic deafness, known familial deafness linked to mutations in other genes than OTOF or GJB2; * Documented genotyping results showing pathogenic mutation(s) in other gene(s) than GJB2 or OTOF genes in the tested panel; * Unable and/or unwilling to comply with all the protocol requirements and/or study procedures.
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What it tests

  • Pure Tone Audiometry Assessment
  • Quality of Life Questionnaires
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Where

1 site
Necker Hospital
Paris, France
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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