Congenital Hearing LossGene TherapySpeech PerceptionRehabilitationReliability and Validity
Investigational drug(s) / intervention(s)
Rehabilitation training
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.
Study 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
Sex
ALL
Min age
1 Year
Max age
35 Years
Healthy volunteers
Accepted
Inclusion Criteria:
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 Criteria:
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.
Primary outcome measure(s)
Reliability — Baseline The reliability of the evaluation system were assessed using Cronbach's α coefficient .
Reliability — Baseline and 1-4 weeks later. The test-retest reliability of the evaluation system were assessed using Pearson correlation coefficient.
Validity — Baseline The validity of the evaluation system were assessed using Exploratory Factor Analysis, EFA and/or Confirmatory Factor Analysis, CFA.
Trial sites (1)
Facility
City
Region
Status
Eye & ENT Hospital of Fudan University
Shanghai
China
Recruiting
More Eye & ENT Hospital of Fudan University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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