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Recruiting Observational

Otoferlin Gene-mediated Hearing Loss Natural History Study

NCT05572073 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2022-07-14
Last updated
2026-03-04

Condition(s) studied

Sensorineural Hearing Loss, Bilateral

Investigational drug(s) / intervention(s)

Natural History Study

Natural History Study: Natural History Study

Study summary

This is a retrospective and prospective longitudinal study in participants with Otoferlin Gene-Mediated Hearing Loss.

Eligibility

Sex
ALL
Min age
—
Max age
44 Years
Healthy volunteers
No
Inclusion Criteria: 1. Clinical presentation of bilateral sensorineural hearing loss (SNHL), including auditory neuropathy (AN) / auditory neuropathy spectrum disorder (ANSD) phenotype or medical history of AN / ANSD phenotype earlier in life 2. Mutation(s) in the otoferlin gene 3. Able and willing to comply with all study requirements, as evidenced by successful completion of the informed consent (and assent, if applicable) process Additional Criteria for Inclusion in the Prospective Phase: 4. Presence of OAE / CM and absent / abnormal ABRs in at least one ear (that does not have a cochlear implant) within 12 months prior to or at the Month 0 visit Exclusion Criteria: 1. Unwillingness or inability of the potential participant and/or legally authorized representative to comply with all protocol requirements 2. Presence of cochlear nerve deficiency and/or cochlear nerve dysplasia Additional Criteria for Exclusion from the Prospective Phase: 3. Presence of bilateral cochlear implants at the time of record review or planned within the next 6 months 4. Presence of middle ear or auditory brainstem implant(s) at the time of record review or planned within the next 6 months 5. Any condition that would not allow the potential participant to complete follow-up assessments during the course of the study and/or, in the opinion of the Investigator, makes the potential participant unsuitable for the study Note: Potential participants will not be excluded based on their sex, gender, race, or ethnicity

Primary outcome measure(s)

  • ABR — First audiologic data in participant medical record through five-year prospective follow up
    Auditory Brainstem Response

Trial sites (10)

FacilityCityRegionStatus
University of Iowa Iowa City Iowa Recruiting
Cincinnati Children's Hospital Medical Center Cincinnati Ohio Recruiting
Children's Hospital of Philadelphia Philadelphia Pennsylvania Recruiting
Vanderbilt University Medical Center Nashville Tennessee Recruiting
Murdoch Children's Research Institute Parkville Victoria Withdrawn
University Hospital in Tübingen Tübingen Germany Recruiting
Sant Joan de Déu Barcelona Hospital Esplugues de Llobregat Barcelona Recruiting
National Taiwan University Hospital Taipei Taiwan Recruiting
Ankara University Ankara Turkey Recruiting
University College London London United Kingdom Recruiting

More Akouos, Inc. trials in Spain

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05572073 on ClinicalTrials.gov ↗ ← All trials in Spain