Comparing speech perception in cochlear implant patients and those receiving gene therapy for hearing loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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, 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 with the assistance of their guardians 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 revealed by CT/MRI scans performed within the past 3 months that may affect the therapeutic effect, vestibular-cochlear nerve abnormalities, acute/chronic otitis media, Meniere's disease, etc.

Presence of other severe congenital diseases. Presence of severe systemic diseases or diseases in the acute phase, 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 to surgery or anesthesia, as 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 it's running

• Eye & ENT Hospital of Fudan University
  Shanghai, Shanghai Municipality, China Recruiting
• 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
• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-term hearing and speech outcomes after cochlear implants

  This project will see if cochlear implants improve hearing, speech understanding, and quality of life in Mandarin-speaking patients of all ages before and after surgery.

  Recruiting Eye & ENT Hospital of Fudan University · Shanghai · NCT07380269

• WhatsApp AI support vs paper support for first-time hearing aid users

  This study tests whether a WhatsApp-based AI support program helps adults with new hearing aids in LMIC communities use and feel confident about their devices better than a paper pamphlet.

  Recruiting at 2 sites University of Pretoria · Pretoria, Province and 1 other locations · NCT07690670

• Hearing and Brain Development in Children and Teens

  This observational study tests how hearing care paths (like hearing aids, cochlear implants, brainstem implants, gene therapy, or no intervention) relate to hearing, speech, language, and brain development in kids and teens, with a normal-hearing group for comparison.

  Recruiting Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Shanghai · NCT07625462

• Web-based auditory training with easy versus hard task settings to improve speech and listening

  This project will test whether easy or hard versions of a web-based auditory training program help adults with hearing loss improve speech understanding and everyday listening.

  Recruiting University of Nottingham · Nottingham, Nottinghamshire · NCT07506408

• Newborn whole-genome sequencing and genetic disease risk in pregnancy and early life

  This project will collect small biological samples from pregnant families and newborns to try whole-genome sequencing and other multi-omics tests to find genetic disease risks.

  Recruiting Women's Hospital School Of Medicine Zhejiang University · Hangzhou, Zhejiang · NCT07365254

• Clemastine plus engineered sound to improve hearing in noisy environments for age-related central auditory processing disorder

  This trial will test whether taking clemastine while listening to engineered sounds helps people aged 45–65 with age-related central auditory processing disorder hear better in noisy places.

  Recruiting Phase 1/2 University of Colorado, Denver · Aurora, Colorado · NCT07304024

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.