NCT07024524

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Eye & ENT Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 1 Year – 35 Years
• Healthy volunteers: Accepted

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.

Detailed description

For congenital sensorineural hearing loss, the traditional treatment methods are hearing aids and cochlear implantation. In recent years, groundbreaking progress has been made in the field of gene therapy for deafness. However, existing assessment materials and tools are not fully applicable to gene therapy patients. In addition, most assessment materials also show other limitations, including a relatively single assessment dimension with minimal gamified interaction and a lack of age-stratified difficulty levels, etc., which pose challenges in objective and comprehensive evaluation, especially for younger children. There is an urgent need to redesign, optimize, and supplement current assessment tools to more accurately reflect post-treatment multidimensional perceptual function, establish a comprehensive evaluation system, and provide targeted rehabilitation guidance. Therefore, this study aims to upgrade and develop a novel multimodal evaluation and precision rehabilitation system for patients with congenital hearing loss across different ages and various treatment types. Based on the existing assessment materials and software, the proposed system will combine the gamified method and interactive, friendly interface to construct a set of interesting and interactive measurements, integrating auditory speech, music perception, spatial hearing assessment and rehabilitation training. Patients with congenital hearing loss and healthy controls will be recruited to validate the reliability and validity of the evaluation system and the effectiveness of the rehabilitation training, providing reference for clinical application.

Conditions

• Congenital Hearing Loss
• Gene Therapy
• Speech Perception
• Rehabilitation
• Reliability and Validity

Interventions

Type	Name	Description
OTHER	Rehabilitation 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.

Timeline

• Start date: 2025-07-04
• Primary completion: 2028-01-01
• Completion: 2028-05-05
• First posted: 2025-06-17
• Last updated: 2025-07-28

Locations

1 site across 1 country: China