search
Back to results

Localization and Mismatch Negativity (MMNLocA)

Primary Purpose

Deafness

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Specific binaural hearing evaluations
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Deafness focused on measuring Mismatch negativity, EEG, Single sided deafness, Cochlear implant, Asymmetrical hearing loss, Spatial hearing, Binaural hearing, Localization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

For symmetrical hearing subjects:

  • Affiliation to a social security
  • Normal hearing, or mild to moderate symmetrical hearing loss controlled by tone audiometry performed before inclusion (in air conduction and bone conduction, frequencies 250 Hz to 4000 Hz).
  • Signature of the consent form

For subjects with single-sided deafness:

  • Affiliation to a social security
  • Subject having a unilateral deafness controlled by pure-tone audiometry before inclusion (in air conduction and bone conduction, frequencies 250 Hz to 4000 Hz).
  • Signature of the consent form

For subjects with Cochlear Implants:

  • Affiliation to a social security
  • Subject with symmetrical or asymmetrical profound deafness treated by unilateral cochlear implantation.
  • Signature of the consent form

Exclusion Criteria:

  • History of associated neurological disorder
  • Taking psychotropic drugs
  • Persons with complicated social or medical situations

Sites / Locations

  • Oto rhino laryngologieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Symmetrical hearing

Single-sided deafness

Bilateral profound hearing loss treated

Arm Description

Specific binaural hearing evaluations (recognition of sentences in noise, sound source localization) and quality of life (SSQ questionnaire) will be carried out. Thereafter, the electroencephalographic examination will be performed

Specific binaural hearing evaluations (recognition of sentences in noise, sound source localization) and quality of life (SSQ questionnaire) will be carried out. Thereafter, the electroencephalographic examination will be performed

Specific binaural hearing evaluations (recognition of sentences in noise, sound source localization) and quality of life (SSQ questionnaire) will be carried out. Thereafter, the electroencephalographic examination will be performed

Outcomes

Primary Outcome Measures

Characterization of the MMN in the group of subjects with single-sided deafness and the group of CI subjects
Amplitude and latency in MMN recordings

Secondary Outcome Measures

Performances for sound source localization and speech recognition in noise across the different groups
Critical signal-to-noise ratios (SRT for speech reception threshold, signal-to-noise ratio authorizing the correct discrimination of 50 % of the words) obtained in the test of discrimination of the word in the presence of a rival noise MATRIX in condition dichotique, diotique and dichotique inverted.
Speech Spatial Quality of the subjects according to the study group
Speech Spatial Quality (SSQ) questionnaire
Correlation between the characteristics of the localization MMN, the behavioral performances for sound source localization and the speech recognition in noise, and the level of quality of life according to the study group
Coefficient of correlation between the characteristics of the MMN of location and the performances of location Coefficient of correlation between the characteristics of the MMN of location and the SRT obtained in the test of discrimination of the word Coefficient of correlation between the characteristics of the MMN of location and the score obtained in the SSQ

Full Information

First Posted
July 19, 2018
Last Updated
August 22, 2023
Sponsor
University Hospital, Toulouse
search

1. Study Identification

Unique Protocol Identification Number
NCT03632551
Brief Title
Localization and Mismatch Negativity
Acronym
MMNLocA
Official Title
Localization and Mismatch Negativity in Subjects With Single-sided Deafness Ads Subjects With Unilateral Cochlear Implant
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2018 (Actual)
Primary Completion Date
December 10, 2020 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This descriptive and observational research project aims to characterize MMN as a neuronal marker of localization deficit in single-sided deafened subjects and subjects with bilateral profound deafness treated by a cochlear implant (CI). It includes several electro-physiological and psychoacoustic assessments performed on subjects with single-sided deafness and cochlear implanted subjects, with normal-hearing subjects as control: Evaluation of the characteristics of the MMN involved in sound localization by EEG. Evaluation of the spatial localization abilities for a sound source presented in the open field. Assessment of performance for speech recognition in noise. These evaluations are performed in subjects with symmetrical hearing, in a natural binaural condition and a monaural condition (with a plugged ear), in subjects with single-sided deafness and in subjects with unilateral CI
Detailed Description
Sound localization is the primary function of binaural hearing and facilitates speech recognition in noise. In case of unilateral or asymmetrical hearing loss, speech recognition in noise requires a constant adaptation of the head position to compensate for deafness. There is a significant impact of these deficits for socio-professional integration with a globally reduced quality of life . A researcher has found a significant correlation between performance for speech recognition in noise and the level of quality of life level assessed by a Spatial and Qualitative Hearing Scale (SSQ). Subjects with bilateral profound deafness treated with cochlear implant (CI) usually recover excellent scores for speech recognition in quiet conditions. Nevertheless, hearing restoration is only partial and binaural hearing includes the fields where hearing remains impaired, as illustrated by the studies on sound localization or speech recognition in noise. Studies using functional MRI, MEG or EEG to investigate neuro-functional reorganization following single-sided deafness show a reduced asymmetry in the hemispherical processing of auditory information, documented by an increase of cortical activity ipsilateral to the better ear, whether it is lateralized to right or left. However, the neural modifications underlying spatial hearing processing have hardly not been explored. The mismatch negativity (MMN) is a specific potential, evoked by an auditory stimulation using two sounds almost similar. The presence of this MMN indicates that the auditory system is able to discriminate these 2 sounds, regardless of the subjective feedback reported by the subject. The use of MMN to describe neural reorganization following cochlear implantation is expanding. Stimuli as diverse as pure sounds, tonal bursts or phonemes may be used, but to the investigator's knowledge there is no study investigating localization processes

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deafness
Keywords
Mismatch negativity, EEG, Single sided deafness, Cochlear implant, Asymmetrical hearing loss, Spatial hearing, Binaural hearing, Localization

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Symmetrical hearing
Arm Type
Active Comparator
Arm Description
Specific binaural hearing evaluations (recognition of sentences in noise, sound source localization) and quality of life (SSQ questionnaire) will be carried out. Thereafter, the electroencephalographic examination will be performed
Arm Title
Single-sided deafness
Arm Type
Experimental
Arm Description
Specific binaural hearing evaluations (recognition of sentences in noise, sound source localization) and quality of life (SSQ questionnaire) will be carried out. Thereafter, the electroencephalographic examination will be performed
Arm Title
Bilateral profound hearing loss treated
Arm Type
Experimental
Arm Description
Specific binaural hearing evaluations (recognition of sentences in noise, sound source localization) and quality of life (SSQ questionnaire) will be carried out. Thereafter, the electroencephalographic examination will be performed
Intervention Type
Other
Intervention Name(s)
Specific binaural hearing evaluations
Intervention Description
Specific binaural hearing evaluations (recognition of sentences in noise, sound source localization) and quality of life (SSQ questionnaire) will be carried out. Thereafter, the electroencephalographic examination will be performed
Primary Outcome Measure Information:
Title
Characterization of the MMN in the group of subjects with single-sided deafness and the group of CI subjects
Description
Amplitude and latency in MMN recordings
Time Frame
Inclusion visit
Secondary Outcome Measure Information:
Title
Performances for sound source localization and speech recognition in noise across the different groups
Description
Critical signal-to-noise ratios (SRT for speech reception threshold, signal-to-noise ratio authorizing the correct discrimination of 50 % of the words) obtained in the test of discrimination of the word in the presence of a rival noise MATRIX in condition dichotique, diotique and dichotique inverted.
Time Frame
Inclusion visit
Title
Speech Spatial Quality of the subjects according to the study group
Description
Speech Spatial Quality (SSQ) questionnaire
Time Frame
Inclusion visit
Title
Correlation between the characteristics of the localization MMN, the behavioral performances for sound source localization and the speech recognition in noise, and the level of quality of life according to the study group
Description
Coefficient of correlation between the characteristics of the MMN of location and the performances of location Coefficient of correlation between the characteristics of the MMN of location and the SRT obtained in the test of discrimination of the word Coefficient of correlation between the characteristics of the MMN of location and the score obtained in the SSQ
Time Frame
Inclusion visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: For symmetrical hearing subjects: Affiliation to a social security Normal hearing, or mild to moderate symmetrical hearing loss controlled by tone audiometry performed before inclusion (in air conduction and bone conduction, frequencies 250 Hz to 4000 Hz). Signature of the consent form For subjects with single-sided deafness: Affiliation to a social security Subject having a unilateral deafness controlled by pure-tone audiometry before inclusion (in air conduction and bone conduction, frequencies 250 Hz to 4000 Hz). Signature of the consent form For subjects with Cochlear Implants: Affiliation to a social security Subject with symmetrical or asymmetrical profound deafness treated by unilateral cochlear implantation. Signature of the consent form Exclusion Criteria: History of associated neurological disorder Taking psychotropic drugs Persons with complicated social or medical situations
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soumia TAOUI
Phone
0561777704
Ext
33
Email
taoui.s@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathieu Marx, PU-PH
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oto rhino laryngologie
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soumia TAOUI
Email
taoui.s@chu-toulouse.fr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25998698
Citation
Avan P, Giraudet F, Buki B. Importance of binaural hearing. Audiol Neurootol. 2015;20 Suppl 1:3-6. doi: 10.1159/000380741. Epub 2015 May 19.
Results Reference
background
PubMed Identifier
17077869
Citation
Baguley DM, Humphriss RL, Axon PR, Moffat DA. The clinical characteristics of tinnitus in patients with vestibular schwannoma. Skull Base. 2006 May;16(2):49-58. doi: 10.1055/s-2005-926216.
Results Reference
background
PubMed Identifier
23781211
Citation
Bennemann J, Freigang C, Schroger E, Rubsamen R, Richter N. Resolution of lateral acoustic space assessed by electroencephalography and psychoacoustics. Front Psychol. 2013 Jun 11;4:338. doi: 10.3389/fpsyg.2013.00338. eCollection 2013.
Results Reference
background
PubMed Identifier
25728172
Citation
Budinger E, Brechmann A, Brosch M, Heil P, Konig R, Ohl FW, Scheich H. Auditory cortex 2014 - towards a synthesis of human and animal research. Eur J Neurosci. 2015 Mar;41(5):515-7. doi: 10.1111/ejn.12832. No abstract available.
Results Reference
background
PubMed Identifier
18569102
Citation
Chan JC, Freed DJ, Vermiglio AJ, Soli SD. Evaluation of binaural functions in bilateral cochlear implant users. Int J Audiol. 2008 Jun;47(6):296-310. doi: 10.1080/14992020802075407.
Results Reference
background

Learn more about this trial

Localization and Mismatch Negativity

We'll reach out to this number within 24 hrs