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Recruiting NCT05468567

Three-dimensional Perception of Sounds in Military with Acoustic Trauma

Observational Hearing Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SPHERE protocol : Spatial hearing performances test, French Matrix Test : audiology test of speech in noise perception, SSQ15 questionnaire of life : (The Speech, Spatial and Other Qualities of Hearing Scale).
Who it may be relevant to
Registry conditions: Hearing Loss. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Spatial hearing capacities of soldiers with acoustic trauma are evaluated in ENT consultations with routine tests (i.e. tonal audiometry, voice audiometry). While the results conclude that soldiers with acoustic trauma have sufficient abilities to carry out professional missions, soldiers report recurring complaints of sound localization (spatial hearing), i.e. difficulties in identifying the position of sound sources in their environment. However, there is currently no objective test to identify and objectify these complaints of spatial hearing. The investigators have developed a new approach (SPHERE) based on virtual reality and 3D motion tracking, allowing us to evaluate and record the spatial hearing performance of subject with hearing deficit. This system allowed us to highlight localization deficits in three-dimensional space. This project explores and quantifies the spatial hearing impairments of soldiers with acoustic trauma. The quantification of the spatial hearing capacities will allow to define a specific rehabilitation strategy of spatial hearing deficits.

Interventions

  • Diagnostic test SPHERE protocol : Spatial hearing performances test
    Participants will be instructed to localize a sound emitted in their environment using a virtual reality setup (SPHEAR protocol).
  • Diagnostic test French Matrix Test : audiology test of speech in noise perception
    Intelligibility threshold is the signal-to-noise ratio (in decibels) for which the subject can repeat 50% of the words heard in a dichotic listening.
  • Behavioral SSQ15 questionnaire of life : (The Speech, Spatial and Other Qualities of Hearing Scale)
    The SSQ questionnaire is a clinical subjective scale that allows evaluating of hearing performances in daily life. The questionnaire is divided into 3 main items (A: speech; B: spatial hearing; C: other qualities of hearing) comprising questions with rating scores out of ten.

Primary outcome measures

  • Cumulative error value "3d-D" measuring the spatial hearing performances [Time frame: at Day 1 during the inclusion visit. The test last 30 minutes.]
Secondary outcome measures (2)
  • Correlation between the score obtained in the SSQ and the 3dD auditory spatialization performance. [Time frame: at Day 1 during the inclusion visit.]
  • Correlation between the score obtained in the Framatrix and the 3dD auditory spatialization performance. [Time frame: at Day 1 during the inclusion visit.]

Eligibility criteria

Inclusion criteria

acoustic traumatized military group :

  • Age between 18 and 65 inclusive
  • Active or reserve military personnel
  • Diagnosis of noise trauma for at least one month
  • Regularly followed up in the ENT department of the Desgenettes Army Training Hospital in Lyon or in the medical offices of the Army Medical Centers.
  • Able to understand the experimental instructions
  • Affiliated to a social security scheme
  • Having been informed of the study and having given their agreement to participate normal hearing group :
  • Age between 18 and 65 years inclusive
  • Able to understand the experimental instructions
  • Affiliated to a social security scheme
  • Having been informed of the study and given their agreement to participate

Exclusion criteria

  • Known current or past neurological or psychiatric disorder
  • Oculomotor/visual disorder
  • Bilateral vestibular areflexia
  • Person under court protection, guardianship or curatorship
  • Pregnant or breastfeeding woman
  • Known hearing loss for normal hearing group

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

France · 1 center
  • Hopital Edouard Herriot — Lyon

Identifiers

NCT: NCT05468567 · 69HCL21_0692

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗