NCT03632551

Brief Summary

This descriptive and observational research project aims to characterize MMN as a neuronal marker of localization deficit in single-sided deafened subjects and subjects with bilateral profound deafness treated by a cochlear implant (CI). It includes several electro-physiological and psychoacoustic assessments performed on subjects with single-sided deafness and cochlear implanted subjects, with normal-hearing subjects as control:

  • Evaluation of the characteristics of the MMN involved in sound localization by EEG.
  • Evaluation of the spatial localization abilities for a sound source presented in the open field.
  • Assessment of performance for speech recognition in noise. These evaluations are performed in subjects with symmetrical hearing, in a natural binaural condition and a monaural condition (with a plugged ear), in subjects with single-sided deafness and in subjects with unilateral CI

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2018

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

2.4 years

First QC Date

July 19, 2018

Last Update Submit

August 22, 2023

Conditions

Deafness

Keywords

Mismatch negativityEEGSingle sided deafnessCochlear implantAsymmetrical hearing lossSpatial hearingBinaural hearingLocalization

Outcome Measures

Primary Outcomes (1)

  • Characterization of the MMN in the group of subjects with single-sided deafness and the group of CI subjects

    Amplitude and latency in MMN recordings

    Inclusion visit

Secondary Outcomes (3)

  • Performances for sound source localization and speech recognition in noise across the different groups

    Inclusion visit

  • Speech Spatial Quality of the subjects according to the study group

    Inclusion visit

  • Correlation between the characteristics of the localization MMN, the behavioral performances for sound source localization and the speech recognition in noise, and the level of quality of life according to the study group

    Inclusion visit

Study Arms (3)

Symmetrical hearing

ACTIVE COMPARATOR

Specific binaural hearing evaluations (recognition of sentences in noise, sound source localization) and quality of life (SSQ questionnaire) will be carried out. Thereafter, the electroencephalographic examination will be performed

Other: Specific binaural hearing evaluations

Single-sided deafness

EXPERIMENTAL

Specific binaural hearing evaluations (recognition of sentences in noise, sound source localization) and quality of life (SSQ questionnaire) will be carried out. Thereafter, the electroencephalographic examination will be performed

Other: Specific binaural hearing evaluations

Bilateral profound hearing loss treated

EXPERIMENTAL

Specific binaural hearing evaluations (recognition of sentences in noise, sound source localization) and quality of life (SSQ questionnaire) will be carried out. Thereafter, the electroencephalographic examination will be performed

Other: Specific binaural hearing evaluations

Interventions

Specific binaural hearing evaluationsOTHER

Specific binaural hearing evaluations (recognition of sentences in noise, sound source localization) and quality of life (SSQ questionnaire) will be carried out. Thereafter, the electroencephalographic examination will be performed

Bilateral profound hearing loss treatedSingle-sided deafnessSymmetrical hearing

Eligibility Criteria

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

You may qualify if:

  • For symmetrical hearing subjects:
  • Affiliation to a social security
  • Signature of the consent form
  • For subjects with single-sided deafness:
  • Affiliation to a social security
  • Signature of the consent form
  • For subjects with Cochlear Implants:
  • Affiliation to a social security
  • Subject with symmetrical or asymmetrical profound deafness treated by unilateral cochlear implantation.
  • Signature of the consent form

You may not qualify if:

  • History of associated neurological disorder
  • Taking psychotropic drugs
  • Persons with complicated social or medical situations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oto rhino laryngologie

Toulouse, France

RECRUITING

Related Publications (5)

  • Avan P, Giraudet F, Buki B. Importance of binaural hearing. Audiol Neurootol. 2015;20 Suppl 1:3-6. doi: 10.1159/000380741. Epub 2015 May 19.

    PMID: 25998698BACKGROUND

  • Baguley DM, Humphriss RL, Axon PR, Moffat DA. The clinical characteristics of tinnitus in patients with vestibular schwannoma. Skull Base. 2006 May;16(2):49-58. doi: 10.1055/s-2005-926216.

    PMID: 17077869BACKGROUND

  • Bennemann J, Freigang C, Schroger E, Rubsamen R, Richter N. Resolution of lateral acoustic space assessed by electroencephalography and psychoacoustics. Front Psychol. 2013 Jun 11;4:338. doi: 10.3389/fpsyg.2013.00338. eCollection 2013.

    PMID: 23781211BACKGROUND

  • Budinger E, Brechmann A, Brosch M, Heil P, Konig R, Ohl FW, Scheich H. Auditory cortex 2014 - towards a synthesis of human and animal research. Eur J Neurosci. 2015 Mar;41(5):515-7. doi: 10.1111/ejn.12832. No abstract available.

    PMID: 25728172BACKGROUND

  • Chan JC, Freed DJ, Vermiglio AJ, Soli SD. Evaluation of binaural functions in bilateral cochlear implant users. Int J Audiol. 2008 Jun;47(6):296-310. doi: 10.1080/14992020802075407.

    PMID: 18569102BACKGROUND

MeSH Terms

Conditions

Deafness

Condition Hierarchy (Ancestors)

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

Study Officials

  • Mathieu Marx, PU-PH

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Soumia TAOUI

CONTACT

0561777704taoui.s@chu-toulouse.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2018

First Posted

August 15, 2018

Study Start

July 10, 2018

Primary Completion

December 10, 2020

Study Completion

December 1, 2023

Last Updated

August 23, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)