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

NCT07417956 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2026-02-25

No results posted yet for this study

Summary

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-subjective and C-eSRT thresholds (r\>0.94; p\<0.001) across all electrodes. Tonal performance remained stable, and speech intelligibility, particularly in noise (FraSiMat), significantly improved with an eSRT-based program after one month of habituation. Daily device use remained stable, reflecting good clinical acceptability. These results support the relevance of systematic integration of eSRT in routine programming.

The aim of the eSRT2 study is to evaluate the feasibility and reliability of eSRT measurement in real-world clinical care for children aged 0 to 7 years, and to monitor its stability during post-operative follow-up. Improved auditory accessibility and better-controlled acoustic comfort through eSRT are expected to accelerate speech development in children by enabling earlier improvements in vocal performance and intelligibility.

Conditions

  • Hearing Loss in Children With Unilateral or Bilateral Cochlear Implants

Interventions

OTHER

Electrically Evoked Stapedius Reflex Threshold (eSRT) Measurement

During routine post-operative programming sessions (at 3, 6, and 12 months), each child will undergo eSRT measurement using a tympanometer placed in the ear canal

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Sabrina BOUZAID · Hôpital Universitaire Necker - Enfants Malades - Service d'ORL et chirurgie cervico-faciale

Eligibility

Min Age
0 Days
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-15
Primary Completion
2029-02-15
Completion
2029-04-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07417956 on ClinicalTrials.gov