Perceptual evaluation and rehabilitation program for congenital hearing loss
Development and Application of A Multimodal Perceptual Evaluation and Precision Rehabilitation System in Congenital Deafness
This project will try a gamified, age‑adjusted software program to measure and train speech, music, and spatial hearing in people born with hearing loss who use hearing aids, cochlear implants, or gene therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 1 Year to 35 Years |
| Sex | All |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07024524 on ClinicalTrials.gov |
What this trial studies
The team will upgrade existing materials and develop a multimodal, gamified software platform with age‑stratified difficulty to test and train auditory speech perception, music perception, and spatial hearing. Participants will include people with congenital sensorineural hearing loss (who have hearing aids, cochlear implants, or gene therapy) and matched normal‑hearing controls. The platform will combine interactive tasks and rehabilitation exercises and will be validated across age groups from young children to adults. Outcome measures will focus on reliability, validity, and improvements in perceptual function after targeted training.
Who should consider this trial
Good fit: Ideal candidates are Mandarin‑speaking individuals aged 1–35 years with congenital hearing loss and hearing thresholds ≥65 dB who have received hearing aids, cochlear implants, or gene therapy, as well as age‑ and gender‑matched normal‑hearing controls.
Not a fit: People with other otologic disorders that interfere with testing, non‑Mandarin speakers, or individuals unable to cooperate with tasks (for example due to severe cognitive impairment) are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could provide more accurate, engaging testing and targeted rehabilitation to improve everyday listening and communication for people born with hearing loss.
How similar studies have performed: Existing perceptual assessments and rehabilitation programs work for hearing aids and cochlear implants, but a combined age‑stratified, gamified multimodal system tailored to gene therapy recipients is largely novel and not yet widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai
- Eye & ENT Hospital of Fudan University — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Yilai Shu, M.D.& Ph.D.
- Email: yilai_shu@fudan.edu.cn
- Phone: +86 21 6437 7134
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.