Localization and Mismatch Negativity

NCT ID: NCT03632551

Last Updated: 2023-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-10

Study Completion Date

2023-12-31

Brief Summary

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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

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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

Conditions

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Deafness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Symmetrical hearing

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

Group Type ACTIVE_COMPARATOR

Specific binaural hearing evaluations

Intervention Type OTHER

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

Single-sided deafness

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

Group Type EXPERIMENTAL

Specific binaural hearing evaluations

Intervention Type OTHER

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

Bilateral profound hearing loss treated

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

Group Type EXPERIMENTAL

Specific binaural hearing evaluations

Intervention Type OTHER

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

Interventions

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Specific binaural hearing evaluations

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mathieu Marx, PU-PH

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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Oto rhino laryngologie

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Soumia TAOUI

Role: CONTACT

0561777704 ext. 33

Facility Contacts

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Soumia TAOUI

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 25998698 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17077869 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23781211 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25728172 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18569102 (View on PubMed)

Other Identifiers

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RC31/18/0096

Identifier Type: -

Identifier Source: org_study_id

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