Perceptual Evaluation and Rehabilitation System Development for Congenital Hearing Loss

Recruiting now · Not applicable

Conditions studied: Congenital Hearing Loss, Gene Therapy, Speech Perception, Rehabilitation, Reliability and Validity

In brief

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.

Key facts

Study ID

NCT07024524

Run by

Eye & ENT Hospital of Fudan University

People needed

210

Starts

2025-07-04

Expected to finish

2028-05-05

Last updated by the study team

2025-07-28

Who can join

Age: 1 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Eye & ENT Hospital of Fudan University — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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