NCT03117413

Brief Summary

Our main objective is to study how the extent of reorganization of the central auditory system is related to the binaural integration in cochlear implanted subjects with asymmetric hearing loss. Subjects with asymmetric hearing loss treated with a cochlear implant and a control group of normal hearing subjects will perform two tests for binaural integration (speech recognition in noise and spatial localization) and two tasks of non-linguistic sounds perception.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

November 23, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2019

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

March 10, 2017

Last Update Submit

April 29, 2026

Conditions

Keywords

Cochlear implantationDeafnessAuditory cortexAuditory plasticityTinnitus

Outcome Measures

Primary Outcomes (1)

  • Differences in auditory brain activation between cochlear implanted asymmetric hearing loss subjects and normal hearing subjects in the binaural condition.

    Prior to the imaging session, patients performed two human voice interpretation tests. link between temporal activations and performances obtained in binaural integration tasks in the patient group.

    Day 1

Secondary Outcomes (4)

  • differences in auditory brain activation.

    Week 3 - Week 5

  • Performance level and the pattern of brain activation.

    Week 3 - Week 5

  • the asymmetry in auditory brain activation for asymmetric hearing loss cochlear implanted subjects.

    Week 3 - Week 5

  • link between binaural hearing performances and auditory brain activation in the binaural condition.

    Week 3 - Week 5

Study Arms (2)

Asymmetric hearing loss

OTHER

Asymmetric hearing loss treated with a cochlear implant will undergo positron emission tomography scan.

Other: Positron emission tomography scan

Normal hearing subjects

OTHER

Normal hearing subjects will undergo positron emission tomography scan.

Other: Positron emission tomography scan

Interventions

* Binaural hearing assessments: speech recognition in noise and sound source localization * Voice perception assessment: voice/non-voice discrimination task, free categorization task * Positron emission tomography examinations under ecological auditory stimuli (voice/non-voice discrimination task)

Asymmetric hearing lossNormal hearing subjects

Eligibility Criteria

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

You may qualify if:

  • cochlear implantation\>3 months
  • signature of informed consent
  • affiliation to social service.

You may not qualify if:

  • associated neurological disorder
  • protected subjects
  • epilepsy episodes
  • psychotropic medication
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de Toulouse - Hôpital Purpan

Toulouse, France, 31059, France

Location

CERCO

Toulouse, Midi-Pyrénées, 31052, France

Location

Related Publications (4)

  • Karoui C, Strelnikov K, Payoux P, Salabert AS, James CJ, Deguine O, Barone P, Marx M. Auditory cortical plasticity after cochlear implantation in asymmetric hearing loss is related to spatial hearing: a PET H215O study. Cereb Cortex. 2023 Feb 20;33(5):2229-2244. doi: 10.1093/cercor/bhac204.

  • Karoui C, James C, Barone P, Bakhos D, Marx M, Macherey O. Searching for the Sound of a Cochlear Implant: Evaluation of Different Vocoder Parameters by Cochlear Implant Users With Single-Sided Deafness. Trends Hear. 2019 Jan-Dec;23:2331216519866029. doi: 10.1177/2331216519866029.

  • Berland A, Collett E, Gaillard P, Guidetti M, Strelnikov K, Cochard N, Barone P, Deguine O. Categorization of everyday sounds by cochlear implanted children. Sci Rep. 2019 Mar 5;9(1):3532. doi: 10.1038/s41598-019-39991-9.

  • Strelnikov K, Collett E, Gaillard P, Truy E, Deguine O, Marx M, Barone P. Categorisation of natural sounds at different stages of auditory recovery in cochlear implant adult deaf patients. Hear Res. 2018 Sep;367:182-194. doi: 10.1016/j.heares.2018.06.006. Epub 2018 Jun 12.

MeSH Terms

Conditions

DeafnessTinnitus

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Mathieu Marx, Pr

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Subjects with asymmetric hearing loss treated with a cochlear implant and a control group of normal hearing subjects
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2017

First Posted

April 18, 2017

Study Start

November 23, 2017

Primary Completion

March 22, 2019

Study Completion

March 22, 2019

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations