NCT01805167

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 6, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

March 6, 2013

Status Verified

February 1, 2013

Enrollment Period

1 year

First QC Date

February 22, 2013

Last Update Submit

March 5, 2013

Conditions

Hearing Loss

Keywords

Subject with cochlear implant

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Comparative study of PEAEP (Auditory Evoked Potentials Early electric) in vocal performance

    At the inclusion - Day 0

Study Arms (1)

subjects with a cochlear implant

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

Interventions

Electrophysiological study of the interindividual variability of vocal performanceOTHER
subjects with a cochlear implant

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, 06000, France

RECRUITING

Related Publications (1)

  • Guevara N, Hoen M, Truy E, Gallego S. A Cochlear Implant Performance Prognostic Test Based on Electrical Field Interactions Evaluated by eABR (Electrical Auditory Brainstem Responses). PLoS One. 2016 May 5;11(5):e0155008. doi: 10.1371/journal.pone.0155008. eCollection 2016.

    PMID: 27149268DERIVED

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nicolas Guevara, Dr

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas GUEVARA, Dr

CONTACT

guevara.n@chu-nice.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2013

First Posted

March 6, 2013

Study Start

February 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

March 6, 2013

Record last verified: 2013-02

Locations

FR(1)