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Feasibility and Reliability of Integrating Electrically Evoked Stapedius Reflex Threshold (eSRT) Measurement in a Pediatric Cochlear Implant Programming Center

Recruitingn/aAges 0 Days - 7 YearsAllAssistance Publique - Hôpitaux de Paris
NCT07417956 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

In children aged 0 to 7 years, behavioral evaluation during cochlear implant programming is often difficult or unreliable. Objective, reproducible, and rapid markers are therefore essential. While objective measures such as ECAP (electrically evoked compound action potentials) help guide safe programming, they can show inter-electrode and inter-subject variability. Electrically evoked stapedius reflex threshold (eSRT) has emerged as a relevant objective marker to approximate the comfort level of stimulation. Pediatric studies indicate that eSRT can be measured in the majority of children, closely corresponds to the comfort level, and is associated with improved speech outcomes when programming is guided by eSRT. In our previous single-center study in children aged 8 to 17 years (N=30; 44 implanted ears), eSRT was obtained in 83.3% of patients, with strong correlation between C-subjectiv

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📋 Eligibility rules (as published)
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.
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What it tests

  • Electrically Evoked Stapedius Reflex Threshold (eSRT) Measurement
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Where

1 site
Hôpital Necker Enfants Malades - Service d'ORL et chirurgie cervico-faciale
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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