Health TrialsbyHealthPanel

The Value Electrical Stapedial Reflex Thresholds (eSRTs) Cochlear Implant Mapping

ConditionsProfound Hearing LossCochlear Implants
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-17
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

Minor patients from 8 years with cochlear implants for at least 1 year and followed by a physician at Hôpital Necker-Enfants malades.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • ESR and ECAP measurements

    Other intervention

    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).

  • Device setting

    Other intervention

    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).

  • Speech audiometry

    Other intervention

    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).

  • Intelligibility in noise test

    Other intervention

    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).

  • Cochlear implant datalogging, speech audiometry test, FraSimat test

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Patients5 interventions

Trial outcomes

Primary outcomes

1

The relationship between the patient's current upper stimulation level (C-subjective) and the measured eSRT

Correlation between the patient's current upper stimulation level (C-subjective) and the measured eSRT measured at the visit 1.

Time frame
Day 0

Secondary outcomes

1

To determine the relationship between the difference between C-subjective and the eSRT and the speech recognition scores

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.

Time frame
Day 0
2

To determine the relationship between the ECAPs (electric compound action potentials) and the eSRT

Correlation between the patient's ECAPs (electric compound action potentials) and the measured eSRT measured at the visit 1.

Time frame
Day 0
3

To evaluate the difference in speech performance in silence obtained using a C-subjective MAP and a C-eSRT MAP

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.

Time frame
1 month
4

To evaluate the difference in speech performance in noise obtained using a C-subjective MAP and a C-eSRT MAP

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.

Time frame
1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator

Source ClinicalTrials.gov
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