Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-01-01 @ 8:11 AM
Study NCT ID:
NCT05468567
Status:
RECRUITING
Last Update Posted:
2024-09-25
First Post:
2022-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Three-dimensional Perception of Sounds in Military with Acoustic Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D006317', 'term': 'Hearing Loss, Noise-Induced'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-23', 'studyFirstSubmitDate': '2022-07-01', 'studyFirstSubmitQcDate': '2022-07-20', 'lastUpdatePostDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative error value "3d-D" measuring the spatial hearing performances', 'timeFrame': 'at Day 1 during the inclusion visit. The test last 30 minutes.', 'description': '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.\n\nThe 3dD performance of the Acoustic traumatised military group will be compared to that of the normal hearing group.'}], 'secondaryOutcomes': [{'measure': 'Correlation between the score obtained in the SSQ and the 3dD auditory spatialization performance.', 'timeFrame': 'at Day 1 during the inclusion visit.', 'description': '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'}, {'measure': 'Correlation between the score obtained in the Framatrix and the 3dD auditory spatialization performance.', 'timeFrame': 'at Day 1 during the inclusion visit.', 'description': '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'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spatial hearing', 'virtual reality', 'acoustic trauma', 'hearing loss'], 'conditions': ['Hearing Loss']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nacoustic traumatized military group :\n\n* Age between 18 and 65 inclusive\n* Active or reserve military personnel\n* Diagnosis of noise trauma for at least one month\n* 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.\n* Able to understand the experimental instructions\n* Affiliated to a social security scheme\n* Having been informed of the study and having given their agreement to participate normal hearing group :\n* Age between 18 and 65 years inclusive\n* Able to understand the experimental instructions\n* Affiliated to a social security scheme\n* Having been informed of the study and given their agreement to participate\n\nExclusion Criteria:\n\n* Known current or past neurological or psychiatric disorder\n* Oculomotor/visual disorder\n* Bilateral vestibular areflexia\n* Person under court protection, guardianship or curatorship\n* Pregnant or breastfeeding woman\n* Known hearing loss for normal hearing group'}, 'identificationModule': {'nctId': 'NCT05468567', 'acronym': 'SPHEAR', 'briefTitle': 'Three-dimensional Perception of Sounds in Military with Acoustic Trauma', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Three-dimensional Perception of Sounds in Military with Acoustic Trauma', 'orgStudyIdInfo': {'id': '69HCL21_0692'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Military person with acoustic trauma (experimental group)', 'description': '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.', 'interventionNames': ['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)']}, {'label': 'Normal hearing volunteers (control group)', 'description': 'Person without known hearing loss.', 'interventionNames': ['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)']}], 'interventions': [{'name': 'SPHERE protocol : Spatial hearing performances test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants will be instructed to localize a sound emitted in their environment using a virtual reality setup (SPHEAR protocol).', 'armGroupLabels': ['Military person with acoustic trauma (experimental group)', 'Normal hearing volunteers (control group)']}, {'name': 'French Matrix Test : audiology test of speech in noise perception', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Military person with acoustic trauma (experimental group)', 'Normal hearing volunteers (control group)']}, {'name': 'SSQ15 questionnaire of life : (The Speech, Spatial and Other Qualities of Hearing Scale)', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Military person with acoustic trauma (experimental group)', 'Normal hearing volunteers (control group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69003', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'ERIC TRUY, MD', 'role': 'CONTACT', 'email': 'eric.truy@chu-lyon.fr', 'phone': '+ 33 4 72 11 05 18'}, {'name': 'ERIC TRUY, MD', 'role': 'CONTACT'}], 'facility': 'Hopital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Eric Truy, Pr', 'role': 'CONTACT', 'email': 'eric.truy@chu-lyon.fr', 'phone': '+33 4 72 11 04 92'}, {'name': 'Marjolaine Beaudoin', 'role': 'CONTACT', 'email': 'Marjolaine.beaudoin@chu-lyon.fr', 'phone': '+ 33 4 72 11 05 18'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}