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Clinical Trials/NCT06013215
NCT06013215Not yet recruitingNot Applicable

PULSE - Paramètres de l'Impulsion électrique et Population Neuronale Chez le Patient implanté cochléaire - Etude en Ouvert, Non contrôlé, Non randomisée

University Hospital, Tours0 sites15 target enrollmentStarted: November 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
15
Primary Endpoint
Calculate the charge integration efficiency along the electrodes

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Calculate the charge integration efficiency along the electrodes

Time Frame: 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 Outcomes

  • Questionnaire between Intensity discrimination and charge integration efficiency(4 hours)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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