Status:

RECRUITING

A Comparative Analysis of Speech Perception Between Cochlear Implant Patients and DFNB9 Patients Receiving Gene Therapy

Lead Sponsor:

Eye & ENT Hospital of Fudan University

Conditions:

Hearing Loss

Genetic Disease

Eligibility:

All Genders

6+ years

Brief Summary

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 efficac...

Detailed Description

Cochlear implant patients exhibit improved speech perception in quiet environments after surgery, but their music perception and speech perception under noise are still unsatisfactory. Gene therapy is...

Eligibility Criteria

Inclusion Criteria:

  • Patients with congenital hearing loss with hearing thresholds ≥65 dB receive either gene therapy (previously received gene therapy and standardized postoperative rehabilitation and follow-up or plan to receive gene therapy), or cochlear implant surgery. Healthy participants with bilateral hearing thresholds within the normal range (≤20 dB), generally matched to the gene therapy group and the cochlear implant group by age and sex.
  • Age ≥ 6 months old, regardless of gender.
  • Mandarin Chinese as the native language.
  • Participants and their guardians must provide informed consent before the trial, voluntarily sign a written consent form, and commit to follow-up at specified time points.
  • Capable of effective communication with researchers under the guardian's assistance and willing to cooperate and comply with the researchers' requirements.
  • The participant's guardians should have a correct understanding of the trial and appropriate expectations regarding potential benefits.

Exclusion Criteria:

  • Presence of other otological disorders that may interfere with the surgical outcome or interpretation of study endpoints, such as middle/inner ear dysplasia or malformations that affected the therapeutic effect revealed in CT/MRI scans within 3 months, vestibular-cochlear nerve abnormalities, acute/chronic otitis media, Meniere's disease, etc.
  • Presence of other severe congenital diseases.
  • Presence of severe systemic diseases or in the acute onset of diseases, such as pulmonary tuberculosis, active hepatitis B or C infection, active herpes zoster infection, pancreatitis, renal insufficiency, etc.
  • Individuals with low immunity, a history of immune deficiency or organ transplantation.
  • Individuals with a history of neurological or mental disorders, such as epilepsy or dementia.
  • Patients with contraindications for surgery or anesthesia assessed by a surgeon, anesthetist, or designated personnel, such as cardiovascular or cerebrovascular events in the past 6 months, allergies to the planned medications, etc.
  • Gene therapy group: gene therapy did not restore hearing; Cochlear implant group: presence of hereditary syndromic deafness or other conditions that seriously affect the efficacy evaluation.
  • Any other conditions for which the investigators consider the subject unsuitable for participation in this clinical study.

Key Trial Info

Start Date :

April 6 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 22 2026

Estimated Enrollment :

180 Patients enrolled

Trial Details

Trial ID

NCT06237790

Start Date

April 6 2024

End Date

December 22 2026

Last Update

September 4 2025

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100730

2

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China, 450052

3

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China, 410011

4

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China, 330006

A Comparative Analysis of Speech Perception Between Cochlear Implant Patients and DFNB9 Patients Receiving Gene Therapy | DecenTrialz