NCT05468567

Brief Summary

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.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

July 1, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 21, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

March 31, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

3 years

First QC Date

July 1, 2022

Last Update Submit

September 23, 2024

Conditions

Keywords

Spatial hearingvirtual realityacoustic traumahearing loss

Outcome Measures

Primary Outcomes (1)

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

    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.

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

Secondary Outcomes (2)

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

    at Day 1 during the inclusion visit.

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

    at Day 1 during the inclusion visit.

Study Arms (2)

Military person with acoustic trauma (experimental group)

Active or reserve military member, diagnosed with acoustic trauma for at least one month. Participants will be instructed to localize a sound emitted in their environment using a virtual reality setup.

Diagnostic Test: SPHERE protocol : Spatial hearing performances testDiagnostic Test: French Matrix Test : audiology test of speech in noise perceptionBehavioral: SSQ15 questionnaire of life : (The Speech, Spatial and Other Qualities of Hearing Scale)

Normal hearing volunteers (control group)

Person without known hearing loss.

Diagnostic Test: SPHERE protocol : Spatial hearing performances testDiagnostic Test: French Matrix Test : audiology test of speech in noise perceptionBehavioral: SSQ15 questionnaire of life : (The Speech, Spatial and Other Qualities of Hearing Scale)

Interventions

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

Military person with acoustic trauma (experimental group)Normal hearing volunteers (control group)

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.

Military person with acoustic trauma (experimental group)Normal hearing volunteers (control group)

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.

Military person with acoustic trauma (experimental group)Normal hearing volunteers (control group)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The Army Training Hospital of Lyon or within the medical branches of the Army Medical Centers are the structures where the soldiers will recruited. The Neurosciences research Center of Lyon or the ENT department of Edouard Herriot Hospital will recruit the normal hearing volunteers.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Edouard Herriot

Lyon, 69003, France

RECRUITING

MeSH Terms

Conditions

Hearing LossHearing Loss, Noise-Induced

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHearing Loss, Sensorineural

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2022

First Posted

July 21, 2022

Study Start

March 31, 2023

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

September 25, 2024

Record last verified: 2024-09

Locations