The Value of Electrical Stapedial Reflex Thresholds (eSRTs) in Determining Upper Stimulation Levels in Cochlear Implant Maps

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 17
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hôpital Necker-Enfants Malades
RECRUITING
Paris
Contact Information
Primary
Nara Vaez-Leppin
nara.vaez-leppin@aphp.fr
0187892914
Backup
Hélène Morel
helene.morel@aphp.fr
0171196346
Time Frame
Start Date: 2023-12-07
Estimated Completion Date: 2026-01-07
Participants
Target number of participants: 30
Treatments
Patients
Minor patients from 8 years with cochlear implants for at least 1 year and followed at Hôpital Necker-Enfants malades.
Related Therapeutic Areas
Sponsors
Collaborators: URC-CIC Paris Descartes Necker Cochin
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov

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