RECRUITING

Otoferlin Gene-mediated Hearing Loss Natural History Study

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Conditions

Sensorineural Hearing Loss, BilateralOtoferlin Gene, sensorineural hearing loss (SNHL), auditory neuropathy, auditory neuropathy spectrum disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Natural History Study in Individuals With Otoferlin Gene-mediated Hearing Loss

Quick Facts

Study Start:2022-07-14
Study Completion:2029-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05572073

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 44 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Mutation(s) in the otoferlin gene
  3. 3. Able and willing to comply with all study requirements, as evidenced by successful completion of the informed consent (and assent, if applicable) process
  4. 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
  1. 1. Unwillingness or inability of the potential participant and/or legally authorized representative to comply with all protocol requirements
  2. 2. Presence of cochlear nerve deficiency and/or cochlear nerve dysplasia
  3. 3. Presence of bilateral cochlear implants at the time of record review or planned within the next 6 months
  4. 4. Presence of middle ear or auditory brainstem implant(s) at the time of record review or planned within the next 6 months
  5. 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

Contacts and Locations

Study Contact

Akouos Clinical Trials
CONTACT
(1) 8574101816
AkouosClinicalTrials@Lilly.com

Principal Investigator

Kathy Reape, MD
STUDY_DIRECTOR
Akouos, Inc.

Study Locations (Sites)

University of Iowa
Iowa City, Iowa, 52242
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-8605
United States

Collaborators and Investigators

Sponsor: Akouos, Inc.

  • Kathy Reape, MD, STUDY_DIRECTOR, Akouos, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-14
Study Completion Date2029-02

Study Record Updates

Study Start Date2022-07-14
Study Completion Date2029-02

Terms related to this study

Keywords Provided by Researchers

  • Otoferlin Gene, sensorineural hearing loss (SNHL), auditory neuropathy, auditory neuropathy spectrum disorder

Additional Relevant MeSH Terms

  • Sensorineural Hearing Loss, Bilateral