DeafnessMMNLocANCT03632551
Localization and Mismatch Negativity
A study testing Specific binaural hearing evaluations in people with Deafness, run by University Hospital, Toulouse at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deafness
- What is being tested?
- Specific binaural hearing evaluations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jul 2018to 11 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- History of associated neurological disorder
- Taking psychotropic drugs
- Persons with complicated social or medical situations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Localization and Mismatch Negativity in Subjects With Single-sided Deafness Ads Subjects With Unilateral Cochlear Implant
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
Read the 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
- Conditions
- Deafness
- Being tested
- Specific binaural hearing evaluations
- Keywords
- Mismatch negativity, EEG, Single sided deafness, Cochlear implant, Asymmetrical hearing loss, Spatial hearing, Binaural hearing, Localization
- Medical subject headings
- Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific binaural hearing evaluationsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Symmetrical hearing | Active comparator | 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 Receives: Other: Specific binaural hearing evaluations |
| Single-sided deafness | Experimental | 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 Receives: Other: Specific binaural hearing evaluations |
| Bilateral profound hearing loss treated | Experimental | 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 Receives: Other: Specific binaural hearing evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Inclusion visit
Secondary outcomes (3)
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.
Measured: Inclusion visit
Speech Spatial Quality of the subjects according to the study group
Speech Spatial Quality (SSQ) questionnaire
Measured: Inclusion visit
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
Measured: Inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start10 Jul 2018
- Primary completion10 Dec 2020
- Study completion11 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DeafnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathieu Marx, PU-PH, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632551
- Sponsor's protocol ID
- RC31/18/0096
- Acronym
- MMNLocA
- Status last verified
- Sep 2026
- First submitted
- 19 Jul 2018
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25998698Baguley 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.
PubMed 17077869Bennemann 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.
PubMed 23781211Budinger 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.
PubMed 25728172Chan 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.
PubMed 18569102
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Localization and Mismatch Negativity in Subjects With Single-sided Deafness Ads Subjects With Unilateral Cochlear Implant
- ClinicalTrials.gov ID
- NCT03632551
- Acronym / sponsor ID
- MMNLocA / RC31/18/0096
- Conditions
- Deafness
- Keywords
- Mismatch negativity, EEG, Single sided deafness, Cochlear implant, Asymmetrical hearing loss, Spatial hearing, Binaural hearing, Localization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 11 Jul 2022 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Symmetrical hearing | Active comparator | Other: Specific binaural hearing evaluationsSpecific 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 | Experimental | Other: Specific binaural hearing evaluationsSpecific 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 | Experimental | Other: Specific binaural hearing evaluationsSpecific 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- 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).
Key exclusion criteria (3 listed)
- History of associated neurological disorder
- Taking psychotropic drugs
- Persons with complicated social or medical situations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific binaural hearing evaluationsSpecific 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 | Other | Bilateral profound hearing loss treated, Single-sided deafness, Symmetrical hearing |
Primary outcome
Characterization of the MMN in the group of subjects with single-sided deafness and the group of CI subjects
Time frame: Inclusion visit
Amplitude and latency in MMN recordings
3 secondary outcomes
Performances for sound source localization and speech recognition in noise across the different groups
Time frame: Inclusion visit
Speech Spatial Quality of the subjects according to the study group
Time frame: Inclusion visit
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
Time frame: Inclusion visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 25998698Avan 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.
- Background: PubMed 17077869Baguley 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.
- Background: PubMed 23781211Bennemann 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.
- Background: PubMed 25728172Budinger 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.
- Background: PubMed 18569102Chan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathieu Marx, PU-PH principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific binaural hearing evaluations in people with Deafness, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of the MMN in the group of subjects with single-sided deafness and the group of CI subjects (time frame: Inclusion visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03632551, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.