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

February 13, 2018 updated by: University Hospital, Toulouse

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31000
        • University Hospital of Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Associated neurological disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Other: control group
Normal hearing subject functional magnetic resonance imaging
Other: functional magnetic resonance imaging
functional magnetic resonance imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks
Speech Reception Threshold
Time Frame: 4 weeks
signal / noise ratio for the recognition of 50% of the words in dichotic hearing
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SRT in reverse dichotic hearing, mean localization error angle
Time Frame: 4 weeks
4 weeks
the percentage of errors in test horizontal location of the sound source
Time Frame: 4 weeks
4 weeks
seniority of deafness
Time Frame: inclusion
requested information to the patient OR recovered in his medical file
inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Mathieu Marx, MD, University Hospital of Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

June 10, 2015

First Submitted That Met QC Criteria

August 24, 2015

First Posted (Estimate)

August 27, 2015

Study Record Updates

Last Update Posted (Actual)

February 15, 2018

Last Update Submitted That Met QC Criteria

February 13, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/13/0204
  • 13 204 02 (Other Identifier: University Hospital Toulouse, 2013, DRCI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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