RecruitingNot ApplicableNCT07024524

Perceptual Evaluation and Rehabilitation System Development for Congenital Hearing Loss

Development and Application of A Multimodal Perceptual Evaluation and Precision Rehabilitation System in Congenital Deafness


Sponsor

Eye & ENT Hospital of Fudan University

Enrollment

210 participants

Start Date

Jul 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to establish a novel multimodal evaluation and precision rehabilitation system for patients with congenital hearing loss who have received hearing aids, cochlear implantation, or emerging gene therapy. The proposed system will integrate age-stratified difficulty levels, combined with a gamified interaction platform or software designed to assess and train three core perceptual domains: auditory speech perception, music perception, and spatial hearing capabilities.


Eligibility

Min Age: 1 YearMax Age: 35 Years

Inclusion Criteria5

  • For Congenital Deafness Group: Patients with congenital hearing loss with hearing thresholds ≥65 dB who have received hearing aids, cochlear implantation, or gene therapy; Age between 1 and 35 years old, regardless of gender.
  • For Healthy Controls Group: Participants with normal hearing thresholds (≤20 dB) whose age and gender matched to the patient group.
  • Mandarin Chinese as the native language. Participants and/or their guardians must provide informed consent before the trial, voluntarily sign a written consent form, and commit to receive evaluation 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.
  • Participants and/or their guardians should have a correct understanding of the trial and appropriate expectations regarding potential benefits.

Exclusion Criteria5

  • Presence of other otological disorders that may interfere with the surgical outcome or interpretation of study endpoints, such as otitis media, Meniere's disease, etc.
  • Presence of other severe congenital diseases, such as congenital heart disease. 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, mental disorders, or moderate-to-severe cognitive dysfunction, such as epilepsy, dementia, autism spectrum disorders, etc.
  • Any other conditions for which the investigators consider the subject unsuitable for participation in this clinical study.

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Interventions

OTHERRehabilitation training

This study constructed a novel multimodal assessment system to evaluate speech perception, music perception, and spatial hearing in congenital deafness patients , and subsequently generated targeted rehabilitation training plan based on the assessment data.


Locations(1)

Eye & ENT Hospital of Fudan University

Shanghai, China

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NCT07024524


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