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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 35
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
Eye & ENT Hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Yilai Shu, M.D.& Ph.D.
yilai_shu@fudan.edu.cn
+86 21 6437 7134
Time Frame
Start Date: 2025-07-04
Estimated Completion Date: 2028-05-05
Participants
Target number of participants: 210
Treatments
Experimental: Congenital Hearing Loss Group
The study will recruit patients with congenital hearing loss with hearing thresholds ≥65 dB who have received hearing aids, cochlear implantation, or gene therapy.
No_intervention: Healthy Controls Group
The study will recruit participants with normal hearing thresholds (≤20 dB) whose age and gender were matched to the patient group.Stage 1 involved an observational study for reliability and validity assessment, enrolling both healthy subjects and congenital deafness patients . Stage 2 involved an interventional study for rehabilitation training, which included congenital deafness patients .Healthy Controls Group were only enrolled in the Stage 1 for reliability and validity assessment, but not the Stage 2 for rehabilitation training.
Sponsors
Leads: Eye & ENT Hospital of Fudan University
Collaborators: Shanghai Rehabilitation Institute for the Exceptional Children

This content was sourced from clinicaltrials.gov