See if eSRT helps set comfort levels in kids with cochlear implants
Official title: Feasibility and Reliability of Integrating Electrically Evoked Stapedius Reflex Threshold (eSRT) Measurement in a Pediatric Cochlear Implant Programming Center
Run by Assistance Publique - Hôpitaux de Paris · NCT07417956 · Data updated 2026-11-12
This study tests whether measuring electrically evoked stapedius reflex threshold (eSRT) can help customize cochlear implant settings for children up to age 7.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Days to 7 Years |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris, Île-de-France Region) |
| Status | Recruiting |
| Started | June 15, 2026 |
| Main results expected | June 15, 2029 |
| Study ends | August 15, 2029 |
| Registry record updated | August 10, 2026 |
| Trial ID | NCT07417956 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 0 to 7 years with unilateral or bilateral cochlear implants and a normal tympanogram.
✕Probably not a fit
Patients with severe neurological issues, unstable middle ear conditions on the day of inclusion, facial nerve or stapedius muscle abnormalities, severe developmental delays, or non-fluent in oral French may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In young children, behavioral responses during cochlear implant programming can be unreliable. This observational study evaluates the feasibility and reliability of using eSRT as an objective, rapid marker to approximate comfortable stimulation levels across different implant brands. The approach compares eSRT measurements with traditional thresholds to determine alignment and consistency, aiming to improve programming safety and outcomes. The study includes children with unilateral or bilateral implants and excludes those with conditions that could confound reflex measurements. Results from prior pediatric work suggest high detectability of eSRT and strong correlation with comfort levels, supporting its potential clinical utility.
Why it matters
Potential benefit: If successful, eSRT-guided programming could provide a more reliable and efficient way to set stimulation levels for children, potentially improving speech outcomes and comfort.
How similar studies have gone: Previous pediatric studies have shown feasibility and strong correlation of eSRT with comfort levels, though broader pediatric data remain limited and further validation is ongoing.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Child aged 0 to 7 years * Unilateral or bilateral cochlear implant * Normal tympanogram * No objection from either parent or legal guardian Exclusion Criteria: * Severe neurological disorder present before inclusion (identifiable by MRI and/or pediatric neurological assessment) * Unstable middle ear pathology on the day of inclusion (e.g., acute serous otitis, tympanic membrane perforation) * Documented abnormality or lesion of the facial nerve or stapedius muscle * Severe cognitive, psychiatric, or developmental delay at the day of inclusion * Family not fluent in oral French.
Where it's running
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Hôpital Necker Enfants Malades - Service d'ORL et chirurgie cervico-faciale
Paris, Île-de-France Region, France Recruiting
Study contacts
- Principal investigator: Sabrina BOUZAID — Hôpital Universitaire Necker - Enfants Malades - Service d'ORL et chirurgie cervico-faciale
- Study coordinator: Sabrina BOUZAID
- Email: sabrina.bouzaid-ext@aphp.fr
- Phone: 01 87 89 29 14
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.