NCT07024524 Perceptual Evaluation and Rehabilitation System Development for Congenital Hearing Loss
| NCT ID | NCT07024524 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Eye & ENT Hospital of Fudan University |
| Condition | Congenital Hearing Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2025-07-04 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 210 participants in total. It began in 2025-07-04 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07024524 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 35 Years, studying Congenital Hearing Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07024524 currently recruiting?
Yes, NCT07024524 is actively recruiting participants. Contact the research team at yilai_shu@fudan.edu.cn for enrollment information.
Where is the NCT07024524 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07024524 clinical trial?
NCT07024524 is sponsored by Eye & ENT Hospital of Fudan University. The trial plans to enroll 210 participants.