NCT06237790 A Comparative Analysis of Speech Perception Between Cochlear Implant Patients and DFNB9 Patients Receiving Gene Therapy
| NCT ID | NCT06237790 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Eye & ENT Hospital of Fudan University |
| Condition | Hearing Loss |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2024-04-06 |
| Primary Completion | 2025-10-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 180 participants in total. It began in 2024-04-06 with a primary completion date of 2025-10-03.
⚠ 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 cohort study aims to explore the trends and differences in multidimensional perceptual levels of patients after cochlear implants or gene therapy, as well as to comprehensively assess the efficacy of gene therapy for congenital deafness, thus providing a reference for making a well-rounded postoperative rehabilitation protocol for gene therapy patients.
Eligibility Criteria
Inclusion Criteria: * Patients with congenital hearing loss with hearing thresholds ≥65 dB receive either gene therapy (previously received gene therapy and standardized postoperative rehabilitation and follow-up or plan to receive gene therapy), or cochlear implant surgery. Healthy participants with bilateral hearing thresholds within the normal range (≤20 dB), generally matched to the gene therapy group and the cochlear implant group by age and sex. * Age ≥ 6 months old, regardless of gender. * Mandarin Chinese as the native language. * Participants and their guardians must provide informed consent before the trial, voluntarily sign a written consent form, and commit to follow-up 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. * The participant's 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 middle/inner ear dysplasia or malformations that affected the therapeutic effect revealed in CT/MRI scans within 3 months, vestibular-cochlear nerve abnormalities, acute/chronic otitis media, Meniere's disease, etc. * Presence of other severe congenital diseases. * 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 or mental disorders, such as epilepsy or dementia. * Patients with contraindications for surgery or anesthesia assessed by a surgeon, anesthetist, or designated personnel, such as cardiovascular or cerebrovascular events in the past 6 months, allergies to the planned medications, etc. * Gene therapy group: gene therapy did not restore hearing; Cochlear implant group: presence of hereditary syndromic deafness or other conditions that seriously affect the efficacy evaluation. * Any other conditions for which the investigators consider the subject unsuitable for participation in this clinical study.
Contact & Investigator
Yilai Shu, M.D. & Ph.D.
STUDY CHAIR
Eye & ENT Hospital of Fudan University
Frequently Asked Questions
Who can join the NCT06237790 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, studying 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 NCT06237790 currently recruiting?
Yes, NCT06237790 is actively recruiting participants. Contact the research team at yilai_shu@fudan.edu.cn for enrollment information.
Where is the NCT06237790 trial being conducted?
This trial is being conducted at Beijing, China, Zhengzhou, China, Changsha, China, Nanchang, China and 2 additional locations.
Who is sponsoring the NCT06237790 clinical trial?
NCT06237790 is sponsored by Eye & ENT Hospital of Fudan University. The principal investigator is Yilai Shu, M.D. & Ph.D. at Eye & ENT Hospital of Fudan University. The trial plans to enroll 180 participants.