Clinical trial NCT06051006: The Value Electrical Stapedial Reflex Thresholds (eSRTs) Cochlear Implant Mapping
Official title: The Value of Electrical Stapedial Reflex Thresholds (eSRTs) in Determining Upper Stimulation Levels in Cochlear Implant Maps
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Profound Hearing Loss
Cochlear Implants
Keywords: Profound hearing loss
Cochlear implants
Cochlear implant programming
Stapedial reflex
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Minor patients from 8 years with cochlear implants for at least 1 year and followed by a physician at Hôpital Necker-Enfants malades.

Brief summary: One of the most significant challenges in cochlear implant programming, particularly for very young children and those with an associated pathologies, is the measurement of subjective comfort levels (= C-Subjective). Currently, to define this C-Subjective level, patients are presented with a loudness scale and must indicate whether the sound stimulus, sent via the implant, is soft, comfortable, or loud. The lower and upper stimulation levels must be determined for each electrode in order to program the implant. For many patients this can be difficult due to a lack of auditory experience and confusion between the sensation of sound intensity (weak or loud) and frequency (low or high).

A less commonly used but more objective approach to programming upper stimulation levels involves the use of the electrical stapedial reflex threshold (eSRTs) value. eSRTs are a promising measure, given the demonstrated correlation between the threshold that generates a stapedial reflex and the C-subjective level. Furthermore, eSRTs can be recorded in the majority of patients, and can typically be evoked at a comfortable stimulation level i.e. inferior to the uncomfortable level.

The main objective of this study is investigate the link between subjective comfort levels (C-subjective levels) and the eSRT.

Detailed description: One of the most significant challenges in cochlear implant programming, particularly for very young children and those with an associated pathologies, is the measurement of subjective comfort levels (= C-Subjective). Currently, to define this C-Subjective level, patients are presented with a loudness scale and must indicate whether the sound stimulus, sent via the implant, is soft, comfortable, or loud. The lower and upper stimulation levels must be determined for each electrode in order to program the implant. For many patients this can be difficult due to a lack of auditory experience and confusion between the sensation of sound intensity (weak or loud) and frequency (low or high).

For these patients, the adjustment is often based on the dynamic range recommended by the manufacturer in relation to the threshold (lower stimulation level) and/or on the discomfort level (upper stimulation level).

Objective measures such as ECAPs (Electric compound action potentials) are commonly used to estimate upper stimulation levels.

These measurements are useful for confirming electrode function and neuronal response, and some research has shown that these measures are correlated with the upper stimulation level. However, other studies suggest that ECAPs are poor predictors of high (and low) stimulation levels and can show variability between electrodes and between subjects.

A less commonly used but more objective approach to programming upper stimulation levels involves the use of the electrical stapedial reflex threshold (eSRTs) value. eSRTs are a promising measure, given the demonstrated correlation between the threshold that generates a stapedial reflex and the C-subjective level. Furthermore, eSRTs can be recorded in the majority of patients, and can typically be evoked at a comfortable stimulation level i.e. inferior to the uncomfortable level.

The patient settings are known as the MAP, where the upper and lower levels of stimulation are defined.

MAPs using eSRTs to set upper stimulation levels (C-eSRT) have been shown equal or better speech recognition results compared to behavior-based MAPs (intensity scale). Additionally, eSRT-based MAPs have been shown to result in equal sound intensity across all electrodes, and patients tend to prefer eSRT-based MAPs over behavioral MAPs.

The main objective of this study is investigate there is a link between subjective comfort levels (C-subjective levels) and the eSRT.

Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 8-17 years at the time of inclusion with cochlear implants for at least 1 year and followed at Hôpital Necker-Enfants malades
* Use oral French as the main mode of communication
* Have a tonal threshold with the cochlear implant of 40 dB or more
* Have a normal tympanogram
* Have a voice threshold of less than 70% at 30dB HL
* Information and non-opposition of holders of parental authority and minor patients to participate in the study

Exclusion Criteria:

* Present a severe neurological pathology before inclusion (which can be identified by an MRI +/- a neuro-pediatric assessment)
* Present, on inclusion, a cognitive or psychiatric impairment or severe developmental delay
* Be part of a family that does not understand oral French
* Patients under AME (State Medical Aid)

Primary outcomes:
measure: The relationship between the patient's current upper stimulation level (C-subjective) and the measured eSRT
timeFrame: Day 0
Secondary outcomes:
measure: To determine the relationship between the difference between C-subjective and the eSRT and the speech recognition scores
timeFrame: Day 0
measure: To determine the relationship between the ECAPs (electric compound action potentials) and the eSRT
timeFrame: Day 0
measure: To evaluate the difference in speech performance in silence obtained using a C-subjective MAP and a C-eSRT MAP
timeFrame: 1 month
measure: To evaluate the difference in speech performance in noise obtained using a C-subjective MAP and a C-eSRT MAP
timeFrame: 1 month
measure: The difference in average daily use time of C-subjective MAP and a C-eSRT MAP
timeFrame: 1 month
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Melissa MacAskill
role: STUDY_DIRECTOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Nara Vaez-Leppin
role: PRINCIPAL_INVESTIGATOR
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