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

Key facts

Who runs it
Assistance Publique - Hôpitaux de Paris
Where
Paris, FranceSee the site
Trial code
Status
Recruiting
People taking part
48 people, planned
Started
15 Jun 2026
Expected to end
15 Aug 2029
Type of study
Observational
Treatments tested
  • Electrically Evoked Stapedius Reflex Threshold (eSRT) Measurement
Record updated
10 August 2026

Who can take part

Age
0 days to 7 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • Child aged 0 to 7 years
  • Unilateral or bilateral cochlear implant
  • Normal tympanogram
  • No objection from either parent or legal guardian

Who cannot take part

  • 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)
  • Severe cognitive, psychiatric, or developmental delay at the day of inclusion
  • Documented abnormality or lesion of the facial nerve or stapedius muscle
  • Family not fluent in oral French

Where in France

  • Hôpital Necker - Enfants Malades - Service d'ORL et chirurgie cervico-facialeParis, FranceContact: Sabrina BOUZAIDTaking people

About the trial

What the trial wants to find out

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.

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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.

The group in the trial

  • eSRT

    All enrolled children (0-7 years) with unilateral or bilateral cochlear implants will undergo electrically evoked stapedius reflex threshold (eSRT) measurements during routine post-operative programming sessions at 3, 6, and 12 months. The eSRT measurement is complementary to standard programming procedures and does not replace any routine clinical care.

    Treatment: Electrically Evoked Stapedius Reflex Threshold (eSRT) Measurement

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
10 August 2026