Functional Magnetic Resonance Imaging Study of the Central Auditory System After Single Sided Deafness (SSD)
Primary Purpose
Unilateral Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
functional magnetic resonance imaging
Sponsored by
About this trial
This is an interventional basic science trial for Unilateral Hearing Loss focused on measuring single sided deafness., Auditory plasticity, Asymmetrical hearing loss, Cochlear implants, Inter hemispheric asymmetry, Lateralization index, Dichotic hearing
Eligibility Criteria
Inclusion Criteria:
- Right-handed subjects
- SSD confirmed using evoked auditory potentials
Exclusion Criteria:
- Associated neurological disorder
Sites / Locations
- University Hospital of Toulouse
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
single sided deafness
control group
Arm Description
single sided deafness and asymmetrical hearing loss patients functional magnetic resonance imaging
Normal hearing subject functional magnetic resonance imaging
Outcomes
Primary Outcome Measures
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
Speech Reception Threshold
signal / noise ratio for the recognition of 50% of the words in dichotic hearing
Secondary Outcome Measures
SRT in reverse dichotic hearing, mean localization error angle
the percentage of errors in test horizontal location of the sound source
seniority of deafness
requested information to the patient OR recovered in his medical file
Full Information
NCT ID
NCT02534298
First Posted
June 10, 2015
Last Updated
February 13, 2018
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT02534298
Brief Title
Functional Magnetic Resonance Imaging Study of the Central Auditory System After Single Sided Deafness
Acronym
SSD
Official Title
Reorganization of Central Auditory System After Single Sided Deafness: a Functional Magnetic Resonance Imaging Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Hearing Loss
Keywords
single sided deafness., Auditory plasticity, Asymmetrical hearing loss, Cochlear implants, Inter hemispheric asymmetry, Lateralization index, Dichotic hearing
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single sided deafness
Arm Type
Experimental
Arm Description
single sided deafness and asymmetrical hearing loss patients functional magnetic resonance imaging
Arm Title
control group
Arm Type
Other
Arm Description
Normal hearing subject functional magnetic resonance imaging
Intervention Type
Other
Intervention Name(s)
functional magnetic resonance imaging
Intervention Description
functional magnetic resonance imaging
Primary Outcome Measure Information:
Title
Lateralization index
Description
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
Time Frame
4 weeks
Title
Speech Reception Threshold
Description
signal / noise ratio for the recognition of 50% of the words in dichotic hearing
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
SRT in reverse dichotic hearing, mean localization error angle
Time Frame
4 weeks
Title
the percentage of errors in test horizontal location of the sound source
Time Frame
4 weeks
Title
seniority of deafness
Description
requested information to the patient OR recovered in his medical file
Time Frame
inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Right-handed subjects
SSD confirmed using evoked auditory potentials
Exclusion Criteria:
Associated neurological disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathieu Marx, MD
Organizational Affiliation
University Hospital of Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
12. IPD Sharing Statement
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Functional Magnetic Resonance Imaging Study of the Central Auditory System After Single Sided Deafness
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