Unilateral Hearing LossSSDNCT02534298
Functional Magnetic Resonance Imaging Study of the Central Auditory System After Single Sided Deafness
A study testing functional magnetic resonance imaging in people with Unilateral Hearing Loss, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The objective is to study the relation between the reorganization of the central auditory system, and the psychophysical deficits in binaural hearing in subjects with single sided deafness. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Unilateral Hearing Loss
- What is being tested?
- functional magnetic resonance imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2015to Apr 2016
- 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
- Right-handed subjects
- SSD confirmed using evoked auditory potentials
Who cannot join
- Associated neurological disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reorganization of Central Auditory System After Single Sided Deafness: a Functional Magnetic Resonance Imaging Study
The objective is to study the relation between the reorganization of the central auditory system, and the psychophysical deficits in binaural hearing in subjects with single sided deafness.
Read the detailed description
Background Single sided deafness (SSD) and asymmetrical hearing loss are common hearing impairments, and their social consequences are well established. At the central auditory system level, the single sided deafness is associated with a reorganization of auditory temporal cortices that leads to a reduction of inter hemispheric asymmetry.
Purpose : Our main objective is to study the relation between the reorganization of the central auditory system, namely the inter hemispheric asymmetry, and the psychophysical deficits in binaural hearing in subjects with SSD.
Abstract : Binaural hearing enables spatial localization of the sound source and improves speech recognition in a competing noise. SSD and asymmetrical hearing loss are common hearing impairments, which affect 0.3 to 1/1000 children. In the adult population, this prevalence increases with age. The impact of SSD and asymmetrical hearing loss on quality of life indices is well established and some reports underline its consequences in children scholarship. Previous neuro-imaging and electro physiological studies highlighted the reduction of normal inter hemispheric asymmetry in subjects with SSD. To the best of our knowledge, there is no report about the relation between the central auditory system reorganization and its behavioural deficits.
The investigators propose to conduct a study which analyzes the relationship between the reduction of inter hemispheric asymmetry and performance in binaural hearing tests. Thus, the auditory plasticity will be studied using functional magnetic resonance imaging and more specifically BOLD variations in auditory temporal cortices. A set of binaural hearing assessments will be performed, including speech recognition in noise and localization abilities. The correlation between the lateralization ratio and binaural measurements (speech reception threshold (SRT) in dichotic hearing, diotic hearing, reverse dichotic hearing) will be estimated. Likewise, the impact of SSD duration on cortical reorganization and binaural tests will be studied.
- Conditions
- Unilateral Hearing Loss
- Being tested
- functional magnetic resonance imaging
- Keywords
- single sided deafness., Auditory plasticity, Asymmetrical hearing loss, Cochlear implants, Inter hemispheric asymmetry, Lateralization index, Dichotic hearing
- Medical subject headings
- Hearing Loss, Unilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional magnetic resonance imagingOther
functional magnetic resonance imaging
| Study group | Role | What they receive |
|---|---|---|
| single sided deafness | Experimental | single sided deafness and asymmetrical hearing loss patients functional magnetic resonance imaging Receives: Other: functional magnetic resonance imaging |
| control group | Other | Normal hearing subject functional magnetic resonance imaging Receives: Other: functional magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lateralization index
ratio of the BOLD signal (blood oxygenation level dependent) obtained at the superior temporal cortex in response to stimulation of the monaural sound to the ear BOLD signal obtained for the same stimulus presented binaurally
Measured: 4 weeks
Speech Reception Threshold
signal / noise ratio for the recognition of 50% of the words in dichotic hearing
Measured: 4 weeks
Secondary outcomes (3)
SRT in reverse dichotic hearing, mean localization error angle
Measured: 4 weeks
the percentage of errors in test horizontal location of the sound source
Measured: 4 weeks
seniority of deafness
requested information to the patient OR recovered in his medical file
Measured: inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unilateral Hearing LossStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathieu Marx, MD, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534298
- Sponsor's protocol ID
- RC31/13/0204
- Other IDs
- 13 204 02
- Acronym
- SSD
- Status last verified
- Apr 2026
- First submitted
- 10 Jun 2015
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vannson N, James CJ, Fraysse B, Lescure B, Strelnikov K, Deguine O, Barone P, Marx M. Speech-in-noise perception in unilateral hearing loss: Relation to pure-tone thresholds and brainstem plasticity. Neuropsychologia. 2017 Jul 28;102:135-143. doi: 10.1016/j.neuropsychologia.2017.06.013. Epub 2017 Jun 13.
PubMed 28623107
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reorganization of Central Auditory System After Single Sided Deafness: a Functional Magnetic Resonance Imaging Study
- ClinicalTrials.gov ID
- NCT02534298
- Acronym / sponsor ID
- SSD / RC31/13/0204
- Conditions
- Unilateral Hearing Loss
- Keywords
- single sided deafness., Auditory plasticity, Asymmetrical hearing loss, Cochlear implants, Inter hemispheric asymmetry, Lateralization index, Dichotic hearing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 27 Aug 2015 (estimated)
- 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.
The objective is to study the relation between the reorganization of the central auditory system, and the psychophysical deficits in binaural hearing in subjects with single sided deafness.
Detailed description
Background Single sided deafness (SSD) and asymmetrical hearing loss are common hearing impairments, and their social consequences are well established. At the central auditory system level, the single sided deafness is associated with a reorganization of auditory temporal cortices that leads to a reduction of inter hemispheric asymmetry.
Purpose : Our main objective is to study the relation between the reorganization of the central auditory system, namely the inter hemispheric asymmetry, and the psychophysical deficits in binaural hearing in subjects with SSD.
Abstract : Binaural hearing enables spatial localization of the sound source and improves speech recognition in a competing noise. SSD and asymmetrical hearing loss are common hearing impairments, which affect 0.3 to 1/1000 children. In the adult population, this prevalence increases with age. The impact of SSD and asymmetrical hearing loss on quality of life indices is well established and some reports underline its consequences in children scholarship. Previous neuro-imaging and electro physiological studies highlighted the reduction of normal inter hemispheric asymmetry in subjects with SSD. To the best of our knowledge, there is no report about the relation between the central auditory system reorganization and its behavioural deficits.
The investigators propose to conduct a study which analyzes the relationship between the reduction of inter hemispheric asymmetry and performance in binaural hearing tests. Thus, the auditory plasticity will be studied using functional magnetic resonance imaging and more specifically BOLD variations in auditory temporal cortices. A set of binaural hearing assessments will be performed, including speech recognition in noise and localization abilities. The correlation between the lateralization ratio and binaural measurements (speech reception threshold (SRT) in dichotic hearing, diotic hearing, reverse dichotic hearing) will be estimated. Likewise, the impact of SSD duration on cortical reorganization and binaural tests will be studied.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single sided deafness | Experimental | Other: functional magnetic resonance imagingsingle sided deafness and asymmetrical hearing loss patients functional magnetic resonance imaging |
| control group | Other | Other: functional magnetic resonance imagingNormal hearing subject functional magnetic resonance imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Right-handed subjects
- SSD confirmed using evoked auditory potentials
Key exclusion criteria (1 listed)
- Associated neurological disorder
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 |
|---|---|---|
| functional magnetic resonance imagingfunctional magnetic resonance imaging | Other | control group, single sided deafness |
Primary outcome
Lateralization index
Time frame: 4 weeks
ratio of the BOLD signal (blood oxygenation level dependent) obtained at the superior temporal cortex in response to stimulation of the monaural sound to the ear BOLD signal obtained for the same stimulus presented binaurally
Speech Reception Threshold
Time frame: 4 weeks
signal / noise ratio for the recognition of 50% of the words in dichotic hearing
3 secondary outcomes
SRT in reverse dichotic hearing, mean localization error angle
Time frame: 4 weeks
the percentage of errors in test horizontal location of the sound source
Time frame: 4 weeks
seniority of deafness
Time frame: inclusion
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 6 May 2026.
- Results publication: PubMed 28623107Vannson N, James CJ, Fraysse B, Lescure B, Strelnikov K, Deguine O, Barone P, Marx M. Speech-in-noise perception in unilateral hearing loss: Relation to pure-tone thresholds and brainstem plasticity. Neuropsychologia. 2017 Jul 28;102:135-143. doi: 10.1016/j.neuropsychologia.2017.06.013. Epub 2017 Jun 13.
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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, MD principal investigator
University Hospital of 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 functional magnetic resonance imaging in people with Unilateral Hearing Loss, 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 2 inclusion and 1 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 6 May 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?
Lateralization index (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 NCT02534298, which also lists 1 linked publication.
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 6 May 2026.