Clinical Trials in Spain / NCT05572073
Recruiting
Observational
Otoferlin Gene-mediated Hearing Loss Natural History Study
NCT05572073 · tracked via the Priya Life Science Spain tracker
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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
Long Term Follow-up Study of AAVAnc80-hOTOF Gene Therapy
Enrolling by invitation
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