Electrical Impulse Parameters and Neuronal Population in the Cochlear Implanted Patient-PULSE

Not Applicable

Not yet recruiting

• Conditions: Sensorineural Hearing Loss
• Interventions: Other: Cochlear implant (Oticon) stimulation parameter optimization

• Registration Number: NCT06013215
• Lead Sponsor: University Hospital, Tours

Brief Summary

The cochlear implant provides good auditory performance despite high inter-individual variability, but performance in noise remains limited. Modification of the coding strategies could improve these performances. A better characterization of the remaining neuronal population by looking for the charge integration efficiency (which depends on the duration and the amplitude of the electrical pulse) would allow an optimization of the settings by adapting either the duration or the amplitude of the pulse according to the quality of the remaining neuronal population.

Detailed Description

The cochlear implant provides good auditory performance despite high inter-individual variability, but performance in noise remains limited. Modification of the coding strategies could improve these performances. Currently, the intensity perceived by the patient is coded by the duration and the amplitude of the electrical impulse but companies have different approaches and fix one of the two parameters for the setting of the processors. A better characterization of the remaining neuronal population by looking for the charge integration efficiency (which depends on the duration and the amplitude of the electrical pulse) would allow an optimization of the settings by adapting either the duration or the amplitude of the pulse according to the quality of the remaining neuronal population.

Study Timeline

• Study First Submitted: 2023-07-27
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-25
• Last Update Submitted: 2023-08-25
• Study First Posted: 2023-08-28
• Last Update Posted: 2023-08-28
• Study Start: 2023-11-01
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• post-lingually deaf adults with at least one year of cochlear implant experience
• unilateral and bilateral cochlear implant recipients
• Oticon device with Neuro Zti array
• Patient affiliated to french social security
• Consent signed

Exclusion Criteria

• Patients under court protection, guardianship or curatorship

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cochlear implant users with Neuro Zti array	Cochlear implant (Oticon) stimulation parameter optimization	Post-lingually cochlear implant users with 12 months of auditory experience Modifications of pulse parameters to determine the charge integration efficiency which is related with neuron survival population

Primary Outcome Measures

Name	Time	Method
Calculate the charge integration efficiency along the electrodes	4 hours	Charge integration efficiency will be determined for each electrode by noting the minimum and maximum loudness perceived by the patient as function of pulse phase duration and amplitude

Secondary Outcome Measures

Name	Time	Method
Questionnaire between Intensity discrimination and charge integration efficiency	4 hours	3 electrodes that span the range of charge integration efficiency values will be selected as test electrodes. Three intensities will be presented to the patient through the implant and it will be asked to the patient to determine which intensity is higher than the others.