Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 5:49 PM
Study NCT ID:
NCT07417956
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Reliability of Integrating Electrically Evoked Stapedius Reflex Threshold (eSRT) Measurement in a Pediatric Cochlear Implant Programming Center
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Feasibility and Reliability of Integrating Electrically Evoked Stapedius Reflex Threshold (eSRT) Measurement in a Pediatric Cochlear Implant Programming Center
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
eSRT2
Brief 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.
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.
Detailed Description:
Cochlear implant programming relies on determining the patient's auditory dynamic range. This corresponds to identifying, for each electrode, the threshold of first perception (T-level) and the most comfortable level of stimulation (C-level or MCL), which defines the functional stimulation range. Different implant manufacturers (Advanced Bionics, Cochlear, Med-El, Oticon Medical) provide specific recommendations for estimating these upper stimulation levels.
Programming can be performed using behavioral measures or objective measures. Behavioral methods, based on patient responses, are widely used in adults. In children and in patients with associated pathologies, behavioral measures are often difficult due to limited auditory experience and potential confusion between loudness and pitch perception.
Therefore, objective measures are recommended in pediatric populations to assist in programming. ECAP/EAP measures are commonly used but show variable performance depending on the measure and implant manufacturer
Another objective measure, the electrically evoked stapedius reflex threshold (eSRT), shows a strong relationship with comfort levels (C-level/MCL) in both adults and children. eSRT appears to be a relevant tool for guiding programming, especially when subjective measures are limited. Recent studies have optimized the protocol (probe frequencies, reproducibility criteria) and confirmed its feasibility , including in pediatric populations using high-frequency probes (Palani et al., 2022) and normative data in children (Aini, 2022). Combined approaches using ECAP and eSRT to estimate C-levels/MCL are also emerging in pediatric programming .
Functionally, better estimation of the comfort level improves auditory accessibility, which is associated with enhanced speech perception and vocal performance. Over the long term, this supports faster language development in children implanted early.
Our previous eSRT study in children over 8 years old demonstrated a strong correlation between C-subjective and C-eSRT thresholds, and improved speech intelligibility (particularly in noise, FraSiMat) with eSRT-guided maps. These findings support the integration of eSRT into routine programming for pediatric populations.
Programming can be performed using behavioral measures or objective measures. Behavioral methods, based on patient responses, are widely used in adults. In children and in patients with associated pathologies, behavioral measures are often difficult due to limited auditory experience and potential confusion between loudness and pitch perception.
Therefore, objective measures are recommended in pediatric populations to assist in programming. ECAP/EAP measures are commonly used but show variable performance depending on the measure and implant manufacturer
Another objective measure, the electrically evoked stapedius reflex threshold (eSRT), shows a strong relationship with comfort levels (C-level/MCL) in both adults and children. eSRT appears to be a relevant tool for guiding programming, especially when subjective measures are limited. Recent studies have optimized the protocol (probe frequencies, reproducibility criteria) and confirmed its feasibility , including in pediatric populations using high-frequency probes (Palani et al., 2022) and normative data in children (Aini, 2022). Combined approaches using ECAP and eSRT to estimate C-levels/MCL are also emerging in pediatric programming .
Functionally, better estimation of the comfort level improves auditory accessibility, which is associated with enhanced speech perception and vocal performance. Over the long term, this supports faster language development in children implanted early.
Our previous eSRT study in children over 8 years old demonstrated a strong correlation between C-subjective and C-eSRT thresholds, and improved speech intelligibility (particularly in noise, FraSiMat) with eSRT-guided maps. These findings support the integration of eSRT into routine programming for pediatric populations.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IDRCB | OTHER | 2025-A02454-45 | View |