Otoferlin Gene-mediated Hearing Loss Natural History Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 44
SponsorAkouos, Inc.
About this trial
This is a retrospective and prospective longitudinal study in participants with Otoferlin Gene-Mediated Hearing Loss.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
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
Disqualifiers
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
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
Trial population
Individuals with hearing loss due to confirmed otoferlin gene mutation(s)
Trial design
Design model
Case-only
Time perspective
Other
Treatments tested in this trial
Natural History Study
Other interventionNatural History Study
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Retrospective1 intervention
Group B: Prospective1 intervention
Trial outcomes
Primary outcomes
1
ABR
Auditory Brainstem Response
Time frame
First audiologic data in participant medical record through five-year prospective follow upSecondary outcomes
1
OAE
Otoacoustic Emissions
Time frame
First audiologic data in participant medical record through the five-year prospective follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Akouos, Inc.
Lead sponsor
Eli Lilly and Company
Collaborator
Source ClinicalTrials.gov