Otoferlin Gene-mediated Hearing Loss Natural History Study
Recruiting now
Conditions studied: Sensorineural Hearing Loss, Bilateral
In brief
This is a retrospective and prospective longitudinal study in participants with Otoferlin Gene-Mediated Hearing Loss.
Key facts
- Study ID
- NCT05572073
- Run by
- Akouos, Inc.
- People needed
- 150
- Starts
- 2022-07-14
- Expected to finish
- 2029-02-01
- Last updated by the study team
- 2026-03-04
Who can join
Age: any, up to 44. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Mutation(s) in the otoferlin gene
- 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:
- 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
You may not qualify if…
- Unwillingness or inability of the potential participant and/or legally authorized representative to comply with all protocol requirements
- Presence of cochlear nerve deficiency and/or cochlear nerve dysplasia
- Additional Criteria for Exclusion from the Prospective Phase:
- Presence of bilateral cochlear implants at the time of record review or planned within the next 6 months
- Presence of middle ear or auditory brainstem implant(s) at the time of record review or planned within the next 6 months
- 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
Where it is running
- University College London — London, United Kingdom, United Kingdom (enrolling)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
- University of Iowa — Iowa City, Iowa, United States (enrolling)
- University Hospital in Tübingen — Tübingen, Germany (enrolling)
- Sant Joan de Déu Barcelona Hospital — Esplugues de Llobregat, Barcelona, Spain (enrolling)
- National Taiwan University Hospital — Taipei, Taiwan (enrolling)
- Ankara University — Ankara, Turkey, Turkey (Türkiye) (enrolling)
- Murdoch Children's Research Institute — Parkville, Victoria, Australia
Full record on ClinicalTrials.gov
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