The Value Electrical Stapedial Reflex Thresholds (eSRTs) Cochlear Implant Mapping (eSRT)
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| ClinicalTrials.gov Identifier: NCT06051006 |
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Recruitment Status :
Recruiting
First Posted : September 22, 2023
Last Update Posted : February 28, 2024
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Profound Hearing Loss Cochlear Implants | Other: ESR and ECAP measurements Other: Device setting Other: Speech audiometry Other: Intelligibility in noise test Other: Cochlear implant datalogging, speech audiometry test, FraSimat test |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 30 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | The Value of Electrical Stapedial Reflex Thresholds (eSRTs) in Determining Upper Stimulation Levels in Cochlear Implant Maps |
| Actual Study Start Date : | December 7, 2023 |
| Estimated Primary Completion Date : | January 7, 2025 |
| Estimated Study Completion Date : | January 7, 2025 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Patients
Minor patients from 8 years with cochlear implants for at least 1 year and followed at Hôpital Necker-Enfants malades.
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Other: ESR and ECAP measurements
Measurement of electrically evoked stapedial reflexes (ESRT) by stimulation via the cochlear implant. Measurement of the Electric compound action potentials (ECAPs) on the electrodes where the ESRT were performed. The measurements and tests will be performed during a routine visit to the Necker hospital for the adjustment of the cochlear implant (visit 1). Other: Device setting The adjustment will be made by an audioprosthetist at the Center for Research in Audiology at Necker Hospital. The purpose of this setting is to modify the comfort thresholds using the ESR via a correction (according to the literature). The cochlear implant (CI) will therefore be set with the setting using the ESR (setting 2). The basic setting (setting 1) will be stored in memory in the CI. If ever the patient does not support setting 2, he/she will have the possibility of returning to the basic setting, without having to return to the Necker hospital for an additional setting. The measurements and tests will be done during an usual visit of the patient to the Necker hospital for the adjustment of the cochlear implant (visit 1). Other: Speech audiometry This examination is part of the usual care for a patient with a cochlear implant. Fournier's monosyllabic test will be used. The test will be carried out by an audioprosthetist at the Center for Research in Audiology at Necker Hospital. The measurement will be performed under both setting conditions: setting 1 (current setting) and setting 2 (based on ESR). The order of administration will be randomized in order to overcome a training effect. The measurements and tests will be done during an usual visit of the patient to the Necker hospital for the adjustment of the cochlear implant (visit 1). Other: Intelligibility in noise test The FraSimat is a measure of speech perception in noise. The test consists of 14 sentences of 3 words, recorded in the presence of background noise, which the child must listen to and repeat. The background noise remains fixed at 65dB HL and the speech intensity adapts according to the patient's responses. The measurement will be performed under two setting conditions: MAP 1 (current setting) and MAP 2 (setting based on ESR). The order of administration will be randomized in order to overcome a training effect. The measurements and tests will be done during an usual visit of the patient to the Necker hospital for the adjustment of the cochlear implant (visit 1). Other Name: FraSimat Other: Cochlear implant datalogging, speech audiometry test, FraSimat test The follow-up visit (visit 2) will take place 1 month after visit 1 only for patients with a comfort levels threshold (via the eSRT) different from the current threshold (C-subjective). At the start of the visit, cochlear implant datalogging will be recorded to determine the use of both settings (setting 2, using the ESR and setting 1, basic setting) while wearing the cochlear implant. The datalogging will be recorded by an audioprosthetist at the Center for Research in Audiology at Necker Hospital. If the patient has worn the new program (setting 2), the speech audiometry test and the FraSimat test (Intelligibility in noise test) will be performed again with the setting based on ESR. |
- The relationship between the patient's current upper stimulation level (C-subjective) and the measured eSRT [ Time Frame: Day 0 ]Correlation between the patient's current upper stimulation level (C-subjective) and the measured eSRT measured at the visit 1.
- To determine the relationship between the difference between C-subjective and the eSRT and the speech recognition scores [ Time Frame: Day 0 ]Correlation between the difference between C-subjective and the eSRT measured at the visit 1 and the percent correct on the Fournier's monosyllabic word test.
- To determine the relationship between the ECAPs (electric compound action potentials) and the eSRT [ Time Frame: Day 0 ]Correlation between the patient's ECAPs (electric compound action potentials) and the measured eSRT measured at the visit 1.
- To evaluate the difference in speech performance in silence obtained using a C-subjective MAP and a C-eSRT MAP [ Time Frame: 1 month ]Comparison of the percent correct on the Fournier's monosyllabic word test at the visit 1, using the C-subjective MAP and at the visit 2, using the C-eSRT MAP.
- To evaluate the difference in speech performance in noise obtained using a C-subjective MAP and a C-eSRT MAP [ Time Frame: 1 month ]Comparison of the percent correct on the FraSimat speech in noise test at the visit 1, using the C-subjective MAP and at the visit 2, using the C-eSRT MAP.
- The difference in average daily use time of C-subjective MAP and a C-eSRT MAP [ Time Frame: 1 month ]Comparison of the number of average daily hours of use time for the C-subjective MAP and the C-eSRT MAP at the visit 2.
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| Ages Eligible for Study: | 8 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06051006
| Contact: Nara Vaez-Leppin | 1 87 89 29 14 ext +33 | nara.vaez-leppin@aphp.fr | |
| Contact: Hélène Morel | 1 71 19 63 46 ext +33 | helene.morel@aphp.fr |
| France | |
| Hôpital Necker-Enfants Malades | Recruiting |
| Paris, France, 75015 | |
| Contact: Anne-Laure Laget 1 87892914 ext +33 anne-laure.laget@aphp.fr | |
| Principal Investigator: | Anne-Laure Laget | Assistance Publique - Hôpitaux de Paris | |
| Study Director: | Melissa MacAskill | Assistance Publique - Hôpitaux de Paris | |
| Principal Investigator: | Nara Vaez-Leppin | Assistance Publique - Hôpitaux de Paris |
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT06051006 |
| Other Study ID Numbers: |
APHP230584 2023-A00644-41 ( Other Identifier: IDRCB Number ) |
| First Posted: | September 22, 2023 Key Record Dates |
| Last Update Posted: | February 28, 2024 |
| Last Verified: | January 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Profound hearing loss Cochlear implants Cochlear implant programming Stapedial reflex |
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Hearing Loss Deafness Hearing Disorders Ear Diseases |
Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases |