Comparing speech perception in cochlear implant patients and those receiving gene therapy for hearing loss
A Comparative Analysis of Speech Perception Between Cochlear Implant Patients and DFNB9 Patients Receiving Gene Therapy
This study is trying to see how well people with cochlear implants hear and understand speech compared to those who have received gene therapy for hearing loss.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 6 Months and up |
| Sex | All |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Locations | 6 sites (Beijing, Beijing Municipality and 5 other locations) |
| Trial ID | NCT06237790 on ClinicalTrials.gov |
What this trial studies
This observational cohort study investigates the differences in speech perception and auditory capabilities between patients with congenital hearing loss who have received cochlear implants and those who have undergone gene therapy. The study aims to evaluate various perceptual levels, including speech perception in noise and music perception, to understand the efficacy of gene therapy compared to cochlear implants. Participants will be assessed on auditory speech perception, cognitive abilities, psychological status, and auditory cortex development, providing insights into postoperative rehabilitation protocols for gene therapy patients.
Who should consider this trial
Good fit: Ideal candidates include patients aged 6 months and older with congenital hearing loss and hearing thresholds of 65 dB or greater who are receiving either gene therapy or cochlear implants.
Not a fit: Patients with other otological disorders that may affect surgical outcomes or study results may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance rehabilitation strategies for patients with congenital hearing loss, leading to improved speech and auditory perception outcomes.
How similar studies have performed: While gene therapy for congenital hearing loss is a novel approach, previous studies have shown promising results in related areas, indicating potential for success in this comparative analysis.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality and 5 other locations
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Not_yet_recruiting)
- The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
- The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Not_yet_recruiting)
- Eye & ENT Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
- West China Hospital, Sichuan University — Chengdu, Sichuan, China (Not_yet_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.