Auditory Restoration and Outcomes After Gene Therapy and Cochlear Implantation: a PRospective Cohort Analysis (AURORA)

Sponsor
Eye & ENT Hospital of Fudan University
Study ID
NCT06237790
Status
Recruiting
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Conditions

  • Genetic Disease
  • Hearing Loss
  • Speech Perception

Eligibility Criteria

Sex
ALL
Age
6 Months - N/A
Healthy Volunteers
Accepted

Study Details

This cohort study aims to explore the trends and differences in multidimensional perceptual levels of patients after cochlear implants or gene therapy, as well as to comprehensively assess the efficacy of gene therapy for congenital deafness, thus providing a reference for making a well-rounded postoperative rehabilitation protocol for gene therapy patients.

Key Dates

First listed
Feb 1, 2024
Start date
Apr 6, 2024
Status verified
Aug 2026
Primary completion
Oct 10, 2029
Completion
Dec 22, 2029

Study Design

Enrollment
180 participants (estimated)

Arms

  • Arm: Gene Therapy Group
    The study will recruit gene therapy patients who are definitely diagnosed with autosomal recessive deafness 9 (DFNB9).
  • Arm: Cochlear Implant Group
    The study will recruit cochlear implant patients with congenital deafness.

Primary Outcome Measure

Auditory speech perception [ Time Frame: Preoperatively and at 13, 26, and 52 weeks postoperatively, with subsequent assessments every 6 or 12 months up to 5 years after treatment. ]

Central Contacts

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