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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02534298
Other study ID # RC31/13/0204
Secondary ID 13 204 02
Status Completed
Phase N/A
First received June 10, 2015
Last updated February 13, 2018
Start date April 2015
Est. completion date April 2016

Study information

Verified date February 2018
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Right-handed subjects

- SSD confirmed using evoked auditory potentials

Exclusion Criteria:

- Associated neurological disorder

Study Design


Intervention

Other:
functional magnetic resonance imaging
functional magnetic resonance imaging

Locations

Country Name City State
France University Hospital of Toulouse Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 4 weeks
Primary Speech Reception Threshold signal / noise ratio for the recognition of 50% of the words in dichotic hearing 4 weeks
Secondary SRT in reverse dichotic hearing, mean localization error angle 4 weeks
Secondary the percentage of errors in test horizontal location of the sound source 4 weeks
Secondary seniority of deafness requested information to the patient OR recovered in his medical file inclusion
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