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NCT Number: NCT05468567

Three-dimensional Perception of Sounds in Military with Acoustic Trauma

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.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Hearing Loss, Noise-Induced Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPHERE protocol : Spatial hearing performances test

Diagnostic Test

Participants will be instructed to localize a sound emitted in their environment using a virtual reality setup (SPHEAR protocol).

French Matrix Test : audiology test of speech in noise perception

Diagnostic Test

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.

SSQ15 questionnaire of life : (The Speech, Spatial and Other Qualities of Hearing Scale)

Behavioral

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 outcomes

  1. Cumulative error value "3d-D" measuring the spatial hearing performances

    Time frame: at Day 1 during the inclusion visit. The test last 30 minutes.

    First, the pointing error will be computed for azimuth, elevation, and depth, in terms of constant error and variable error. Then, these separate dimension errors will be combined into a cumulative error "3d-D", taking into account absolute and variable error in one measure. 3d-D value corresponding to the spatial hearing deficit matching the distance between the 3D hand pointing position and the 3D sound source position.

    The 3dD performance of the Acoustic traumatised military group will be compared to that of the normal hearing group.

Secondary outcomes

  1. Correlation between the score obtained in the SSQ and the 3dD auditory spatialization performance.

    Time frame: at Day 1 during the inclusion visit.

    The behavioral (dependent) variables from the SSQ of the acoustic traumatized military will be analyzed using the linear regression method to examine the relationship between their 3dD auditory spatialization performance and their SSQ score

  2. Correlation between the score obtained in the Framatrix and the 3dD auditory spatialization performance.

    Time frame: at Day 1 during the inclusion visit.

    The speech-in-noise performance (SNR) of the acoustic traumatized military will be analysed using the linear regression method to examine the relationship between their speech-in-noise performance (SNR) and their SSQ score

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Truy, Pr

CONTACT

[email protected]

+33 4 72 11 04 92

Marjolaine Beaudoin

CONTACT

[email protected]

+ 33 4 72 11 05 18

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: SPHEAR

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 21, 2022
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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