Actively Recruiting

Phase Not Applicable
Age: 1Year - 35Years
All Genders
Healthy Volunteers
NCT07024524

Perceptual Evaluation and Rehabilitation System Development for Congenital Hearing Loss

Led by Eye & ENT Hospital of Fudan University · Updated on 2025-07-28

210

Participants Needed

1

Research Sites

148 weeks

Total Duration

On this page

Sponsors

E

Eye & ENT Hospital of Fudan University

Lead Sponsor

S

Shanghai Rehabilitation Institute for the Exceptional Children

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Perceptual Evaluation and Rehabilitation System Development for Congenital Hearing Loss

Who Can Participate

Age: 1Year - 35Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Healthy controls with normal hearing thresholds (40 dB) matched by age and gender
  • Mandarin Chinese as the native language
  • Participants and/or guardians must provide informed consent and agree to evaluations at specified times
  • Capable of effective communication with researchers with guardian's help and willing to cooperate
  • Participants and/or guardians should understand the trial and have appropriate expectations of benefits
Not Eligible

You will not qualify if you...

  • Other ear disorders that may affect surgery or study results, such as otitis media or Meniere's disease
  • Severe congenital diseases like congenital heart disease
  • Severe systemic or acute diseases including pulmonary tuberculosis, active hepatitis B or C, herpes zoster, pancreatitis, or renal insufficiency
  • Low immunity, immune deficiency history, or organ transplantation
  • History of neurological or mental disorders or moderate-to-severe cognitive dysfunction such as epilepsy, dementia, or autism
  • Any other condition judged unsuitable by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Eye & ENT Hospital of Fudan University

Shanghai, China, 200031

Actively Recruiting

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Research Team

Y

Yilai Shu, M.D.& Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

2

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