Hearing LossSPHEARNCT05468567
Three-dimensional Perception of Sounds in Military with Acoustic Trauma
An observational study of Hearing Loss, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- SPHERE protocol : Spatial hearing performances test, French Matrix Test : audiology test of speech in noise perception and SSQ15 questionnaire of life : (The Speech, Spatial and Other Qualities of Hearing Scale)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2023to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Edouard Herriot
Lyon, 69003
ERIC TRUY, MD, + 33 4 72 11 05 18, eric.truy@chu-lyon.fr
ERIC TRUY, MD
About this study
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.
- Conditions
- Hearing Loss
- Being tested
- 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)
- Keywords
- Spatial hearing, virtual reality, acoustic trauma, hearing loss
- Medical subject headings
- Hearing Loss, Hearing Loss, Noise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPHERE protocol : Spatial hearing performances testDiagnostic 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 perceptionDiagnostic 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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: SPHERE protocol : Spatial hearing performances test; Diagnostic Test: French Matrix Test : audiology test of speech in noise perception; Behavioral: SSQ15 questionnaire of life : (The Speech, Spatial and Other Qualities of Hearing Scale) | |
| Normal hearing volunteers (control group) | Person without known hearing loss. Receives: Diagnostic Test: SPHERE protocol : Spatial hearing performances test; Diagnostic Test: French Matrix Test : audiology test of speech in noise perception; Behavioral: SSQ15 questionnaire of life : (The Speech, Spatial and Other Qualities of Hearing Scale) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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
Measured: at Day 1 during the inclusion visit.
Correlation between the score obtained in the Framatrix and the 3dD auditory spatialization performance.
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
Measured: at Day 1 during the inclusion visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start31 Mar 2023
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468567
- Sponsor's protocol ID
- 69HCL21_0692
- Acronym
- SPHEAR
- Status last verified
- Sep 2024
- First submitted
- 1 Jul 2022
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Perception of Sounds in Military with Acoustic Trauma
- ClinicalTrials.gov ID
- NCT05468567
- Acronym / sponsor ID
- SPHEAR / 69HCL21_0692
- Conditions
- Hearing Loss
- Keywords
- Spatial hearing, virtual reality, acoustic trauma, hearing loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Military person with acoustic trauma (experimental group) | – | Diagnostic Test: SPHERE protocol : Spatial hearing performances test, Diagnostic Test: French Matrix Test : audiology test of speech in noise perception, Behavioral: SSQ15 questionnaire of life : (The Speech, Spatial and Other Qualities of Hearing Scale)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. |
| Normal hearing volunteers (control group) | – | Diagnostic Test: SPHERE protocol : Spatial hearing performances test, Diagnostic Test: French Matrix Test : audiology test of speech in noise perception, Behavioral: SSQ15 questionnaire of life : (The Speech, Spatial and Other Qualities of Hearing Scale)Person without known hearing loss. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPHERE protocol : Spatial hearing performances testParticipants will be instructed to localize a sound emitted in their environment using a virtual reality setup (SPHEAR protocol). | Diagnostic test | Military person with acoustic trauma (experimental group), Normal hearing volunteers (control group) |
| French Matrix Test : audiology test of speech in noise perceptionIntelligibility threshold is the signal-to-noise ratio (in decibels) for which the subject can repeat 50% of the words heard in a dichotic listening. | Diagnostic test | Military person with acoustic trauma (experimental group), Normal hearing volunteers (control group) |
| 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. | Behavioural | Military person with acoustic trauma (experimental group), Normal hearing volunteers (control group) |
Primary outcome
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.
2 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric Truy, Pr (+33 4 72 11 04 92, eric.truy@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative error value "3d-D" measuring the spatial hearing performances (time frame: at Day 1 during the inclusion visit. The test last 30 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.