Electrophysiological Study of Interindividual Differences in Speech-understanding Among Cochlear Implant Patients

Hearing Loss Clinical Trial

Official title:

Electrophysiological Study of Interindividual Differences in Speech-understanding Among Cochlear Implant Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01805167
• Other study ID #: 12-AOI-06
• Secondary ID: 2012-A01374-39
• Status: Recruiting
• Phase: N/A
• First received: February 22, 2013
• Last updated: March 5, 2013
• Start date: February 2013
• Est. completion date: February 2014

Study information

• Verified date: February 2013
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Nicolas GUEVARA, Dr
• Email: guevara.n[@]chu-nice.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Differences in speech-understanding and the quality of the subjective perception among cochlear implant patients (Digisonic SP) depends on numerous factors. The electrical field distribution (interaction between electrodes) could also explain the disparity of the performances? The objective of our study was to quantify the influence of the electrical field interactions between the channels of stimulation according to the vocal performances of the implanted subjects, for various subjective levels of electric stimulation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subject of French language

• Subject with a moderate bilateral sensorineural hearing loss, severe to profound

• Sensorineural hearing loss post-lingual (after onset of language acquisition)

• Subject paired with the implant Neurelec (Appendix 1) for more than 9 months

• Subject has received an appropriate setting under usual clinical follow-up

• Elderly 18 to 75 years

• Subject giving consent

Exclusion Criteria:

• Sensorineural hearing loss pre-lingual

• Deafness following a meningitis, or neurodegenerative diseases

• Illiteracy

• Pregnant women

• Subject blind

• Subject enjoying a measure of legal protection

• Subject incapable of giving consent

• Subject vulnerable

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Other:
• Electrophysiological study of the interindividual variability of vocal performance

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantify the interactions between electrical stimulation channels based vocal performance of implanted subjects, for different subjective levels of electrical stimulation.	The vocal performance will be noted in percentage of voice recognition in the silence and in the noise.; And the electric interaction between the channels of stimulations will be estimated by the measure of the refractory period of the circuits of the hearing system with the PEAEP after stimulations of electrodes of intermediate situation in the cochlée (electrodes 11, 12 and 13)	At the inclusion - Day 0	No
Secondary	Comparative study of PEAEP (Auditory Evoked Potentials Early electric) in vocal performance	Collection of the PEAEP after stimulation of 4 different electrodes distributed on the totality of door-electrode: generally, electrodes 4, 7, 10 and 13 will be stimulated. The amplitudes and the latencies of the waves II, III and V will be analyzed and compared with the vocal performances.	At the inclusion - Day 0	No