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Development of a Battery of Audiological Tests for the Precision Diagnosis of Age-related Hearing Loss

Study acronym: AUDIOGENAGE
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion date: Jul 28, 2024 to Dec 31, 2027
    • Study completion date: Jul 28, 2028 to Dec 31, 2030
    v6
  2. Minor Eligibility criteria expanded, about 26 wordsv5
  3. Minor Re-verified, no change to tracked fieldsv4
  4. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Apr 1, 2024 to Jul 28, 2024
    • Study completion date: Apr 1, 2028 to Jul 28, 2028
    • Start date changed from estimate of May 15, 2022 to Jul 28, 2022
    • Site details revised at 2 of 2 sites
  5. Notable Start date: Apr 15, 2022 to May 15, 2022v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Age-related hearing loss, or presbycusis, is caused by many genetic and environmental factors. Its prevalence poses a public health challenge of early identification and effective hearing aid treatment. However, the lack of screening and of a validated audiological test battery to diagnose an individual's needs and to guide hearing aid adjustments is a major obstacle. Furthermore, monogenic forms of hearing loss affect only one functional module of hearing. The audiological test(s) dependent on the function of this module are affected, in a progressive manner, but not the others. A previous study showed that in early onset presbycusis patients, a quarter of the subjects tested were affected by monogenic presbycusis. The collection of audiological and vestibular tests, carried out on proven monogenic presbycusis patients and compared to that of normal hearing patients, would constitute a battery of tests allowing a precision diagnosis, then developed to all forms of presbycusis in order to study if the identification of abnormal functional modules can usefully guide the diagnosis and the early fitting.
Trial Details
NCT Number NCT05312983
Lead Sponsor Institut Pasteur
Collaborators: CEntre de Recherche et d'Innovation en Audiologie Humaine, Laboratoire de correction auditive
Conditions
(from sponsor)
Presbyacusis
Related terms Presbycusis
Enrollment 700 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov