Otoferlin Gene-mediated Hearing Loss Natural History Study
NCT ID: NCT05572073
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2022-07-14
2029-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
OTHER
Study Groups
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Retrospective
Natural History Study
Natural History Study
Prospective
Natural History Study
Natural History Study
Interventions
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Natural History Study
Natural History Study
Eligibility Criteria
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Inclusion Criteria
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
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
44 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Akouos, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Kathy Reape, MD
Role: STUDY_DIRECTOR
Akouos, Inc.
Locations
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University of Iowa
Iowa City, Iowa, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Murdoch Children's Research Institute
Parkville, Victoria, Australia
University Hospital in Tübingen
Tübingen, , Germany
Sant Joan de Déu Barcelona Hospital
Esplugues de Llobregat, Barcelona, Spain
National Taiwan University Hospital
Taipei, , Taiwan
Ankara University
Ankara, Turkey, Turkey (Türkiye)
University College London
London, United Kingdom, United Kingdom
Countries
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Central Contacts
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Other Identifiers
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AK-OTOF-NHS-002
Identifier Type: -
Identifier Source: org_study_id