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Functional Magnetic Resonance Imaging Study of the Central Auditory System After Single Sided Deafness (SSD)

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ClinicalTrials.gov Identifier: NCT02534298
Recruitment Status : Completed
First Posted : August 27, 2015
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief 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.

Condition or disease Intervention/treatment Phase
Unilateral Hearing Loss Other: functional magnetic resonance imaging Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Reorganization of Central Auditory System After Single Sided Deafness: a Functional Magnetic Resonance Imaging Study
Actual Study Start Date : April 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: single sided deafness
single sided deafness and asymmetrical hearing loss patients functional magnetic resonance imaging
Other: functional magnetic resonance imaging
functional magnetic resonance imaging

control group
Normal hearing subject functional magnetic resonance imaging
Other: functional magnetic resonance imaging
functional magnetic resonance imaging




Primary Outcome Measures :
  1. 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

  2. Speech Reception Threshold [ Time Frame: 4 weeks ]
    signal / noise ratio for the recognition of 50% of the words in dichotic hearing


Secondary Outcome Measures :
  1. SRT in reverse dichotic hearing, mean localization error angle [ Time Frame: 4 weeks ]
  2. the percentage of errors in test horizontal location of the sound source [ Time Frame: 4 weeks ]
  3. seniority of deafness [ Time Frame: inclusion ]
    requested information to the patient OR recovered in his medical file



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Right-handed subjects
  • SSD confirmed using evoked auditory potentials

Exclusion Criteria:

  • Associated neurological disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02534298


Locations
France
University Hospital of Toulouse
Toulouse, France, 31000
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Mathieu Marx, MD University Hospital of Toulouse

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02534298     History of Changes
Other Study ID Numbers: RC31/13/0204
13 204 02 ( Other Identifier: University Hospital Toulouse, 2013, DRCI )
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018

Keywords provided by University Hospital, Toulouse:
single sided deafness.
Auditory plasticity
Asymmetrical hearing loss
Cochlear implants
Inter hemispheric asymmetry
Lateralization index
Dichotic hearing

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Unilateral
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms