NCT02534298

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 27, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

June 10, 2015

Last Update Submit

April 29, 2026

Conditions

Keywords

single sided deafness.Auditory plasticityAsymmetrical hearing lossCochlear implantsInter hemispheric asymmetryLateralization indexDichotic hearing

Outcome Measures

Primary Outcomes (2)

  • 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

  • Speech Reception Threshold

    signal / noise ratio for the recognition of 50% of the words in dichotic hearing

    4 weeks

Secondary Outcomes (3)

  • SRT in reverse dichotic hearing, mean localization error angle

    4 weeks

  • the percentage of errors in test horizontal location of the sound source

    4 weeks

  • seniority of deafness

    inclusion

Study Arms (2)

single sided deafness

EXPERIMENTAL

single sided deafness and asymmetrical hearing loss patients functional magnetic resonance imaging

Other: functional magnetic resonance imaging

control group

OTHER

Normal hearing subject functional magnetic resonance imaging

Other: functional magnetic resonance imaging

Interventions

functional magnetic resonance imaging

control groupsingle sided deafness

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Associated neurological disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Toulouse

Toulouse, 31000, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hearing Loss, Unilateral

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mathieu Marx, MD

    University Hospital of Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2015

First Posted

August 27, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations