Hearing Loss Trial, Recruiting NCT06237790 Sponsor: Eye & ENT Hospital of Fudan University Condition: Hearing Loss
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Hearing Loss Trial, Recruiting

NCT06237790
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People with congenital (present from birth) hearing loss where hearing thresholds are 65 dB or worse, who have already received gene therapy with follow-up care, are planning to receive gene therapy, or have received a cochlear implant.
  • Healthy participants with normal hearing (thresholds of 20 dB or better), broadly matched to the other groups by age and sex.
  • People aged 6 months or older, of any gender.
  • People whose first language is Mandarin Chinese.
  • Participants (and their guardians) who are willing to give written consent, attend follow-up appointments at set time points, and cooperate with the research team's requirements.
  • Participants who are able to communicate effectively with researchers, with help from a guardian if needed.
  • Guardians who have a clear and realistic understanding of what the trial involves and what benefits might reasonably be expected.

Who may not be able to join:

  • People with other ear conditions that could affect surgery outcomes or how results are interpreted — such as middle or inner ear structural abnormalities seen on CT or MRI scans in the past 3 months, nerve abnormalities in the ear, ear infections, or Meniere's disease.
  • People with other serious conditions present from birth.
  • People with severe ongoing illnesses or illnesses in an active stage, such as tuberculosis, active hepatitis B or C, active shingles (herpes zoster), pancreatitis, or kidney insufficiency.
  • People with a weakened immune system, a history of immune deficiency, or a history of organ transplantation.
  • People with a history of neurological or mental health conditions, such as epilepsy or dementia.
  • People who a surgeon, anaesthetist, or designated medical professional considers to have reasons why surgery or anaesthesia would not be safe — for example, a cardiovascular or stroke event in the past 6 months, or known allergies to planned medications.
  • For the gene therapy group: cases where the gene therapy did not result in restored hearing. For the cochlear implant group: people with hereditary syndromic deafness or other conditions that would seriously affect how results are measured (confirm with trial site).
  • Anyone the trial investigators consider unsuitable for participation for any other reason.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Yilai Shu, M.D. & Ph.D., Eye & ENT Hospital of Fudan University

Phone: +86 21 6437 7134

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Eye & ENT Hospital of Fudan University
Registry
ClinicalTrials.gov
Start date
6 April 2024
Est. completion
3 October 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Auditory speech perception; Auditory speech perception; Auditory speech perception; Auditory speech perception; Auditory speech perception; Auditory speech perception; Auditory speech perception

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov