Hearing Loss Trial, Recruiting NCT05670158 Sponsor: University Hospital, Montpellier Condition: Hearing Loss
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Hearing Loss Trial, Recruiting

NCT05670158
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:

For people receiving a cochlear implant:

  • You are 18 years old or older
  • You have been recommended for cochlear implant surgery based on French health authority guidelines, meaning you have severe to profound hearing loss and score 50% or below on a standard speech understanding test
  • You still have some remaining hearing (even if very limited) at certain low-to-mid sound frequencies, measured by a hearing test
  • You are willing and able to give written consent to participate
  • You are covered by the French social security system

For people in the control group (middle ear surgery):

  • You are 18 years old or older
  • You are scheduled for a routine middle ear operation (such as eardrum repair, small bone repair, or treatment for otosclerosis), not related to active infection or inflammation
  • Your inner ear hearing is essentially normal, with a hearing loss of 35 dB or less on a standard hearing test
  • You are willing and able to give written consent to participate
  • You are covered by the French social security system

Who may not be able to join:

For people receiving a cochlear implant:

  • You have a medical reason why surgery would not be safe for you
  • Your pre-surgery inner ear assessment suggests the implant surgery is not suitable
  • You have no remaining hearing at all, as shown by your pre-surgery hearing test
  • You have a history of bacterial infection of the inner ear or bacterial meningitis
  • Imaging scans show that your cochlea (part of the inner ear) has hardened or become blocked
  • Certain specific genetic mutations related to hearing have been identified in your DNA testing (confirm with trial site)
  • You are a minor, a protected adult, pregnant, breastfeeding, under guardianship, or have restricted personal freedom
  • You are currently taking part in another clinical trial involving a drug or medical treatment

For people in the control group (middle ear surgery):

  • You have a medical reason why surgery would not be safe for you
  • Your hearing levels have been shown to go up and down over time in either ear
  • You have a history of bacterial infection of the inner ear or bacterial meningitis
  • You have an active infection or inflammation in your middle ear on the day of surgery
  • You have a long-term immune or inflammatory condition
  • You have an active viral or bacterial infection on the day you join the study or on the day of surgery
  • You have a fever on the day your first blood sample is taken
  • You are a minor, a protected adult, pregnant, breastfeeding, under guardianship, or have restricted personal freedom
  • You are currently taking part in another clinical trial involving a drug or medical treatment

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 26 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

Phone: +33467336890

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

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
7 December 2023
Est. completion
1 March 2026

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Expression levels of proteins and metabolites in the perilymph before surgery in the 2 groups of implanted patients; Expression levels of proteins and metabolites in the blood before surgery in the 2 groups of implanted patients

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: 26 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