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

NCT ID: NCT06013215

Last Updated: 2023-08-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2025-11-01

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.

Conditions

Sensorineural Hearing Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Cochlear implant users with Neuro Zti array

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

Group Type: EXPERIMENTAL

Cochlear implant (Oticon) stimulation parameter optimization

Intervention Type: OTHER

The pulse amplitude and/or the pulse phase duration will be optimize to improve the intensity resolution of the cochlear implant which may benefit speech perception

Interventions

Cochlear implant (Oticon) stimulation parameter optimization

The pulse amplitude and/or the pulse phase duration will be optimize to improve the intensity resolution of the cochlear implant which may benefit speech perception

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Tours

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Bakhos

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Tours

Central Contacts

David Bakhos, MD, PhD

Role: CONTACT

bakhos.david@gmail.com

+33 (0)218370523

Elodie MOUSSET, MSc

Role: CONTACT

E.MOUSSET@chu-tours.fr

+33 (0)247474665

Other Identifiers

2023-A00476-39

Identifier Type: OTHER

Identifier Source: secondary_id

DR230050

Identifier Type: REGISTRY

Identifier Source: secondary_id

DR230050-PULSE

Identifier Type: -

Identifier Source: org_study_id