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Study of the Use of Hearing Protection Equipment in the Occurence of Acute Acoustic Trauma in the Army (QPROTEC)

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ClinicalTrials.gov Identifier: NCT04804982
Recruitment Status : Recruiting
First Posted : March 18, 2021
Last Update Posted : April 2, 2021
Sponsor:
Information provided by (Responsible Party):
Direction Centrale du Service de Santé des Armées

Study Description
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Brief Summary:

Each year, military epidemiological surveillance counts approximately 1,000 acute acoustic injuries. Most are caused by exposure to weapon noise during training sessions while military personnel are provided with hearing protection. Several hypotheses could explain the occurrence of acute acoustic trauma despite wearing protections:

  • A lack of practices or knowledge about the use of hearing protection equipment that could facilitate the occurrence of acute acoustic trauma (improper fitting, use of an inappropriate type of protection, dropping of protectors, inappropriate removal)
  • A failure to seal the external ear canal due to an inappropriate plug size. These hypotheses will be explored using a questionnaire distributed to a population of Army soldiers training to shoot.

The main objective is to determine the predictive factors corresponding to practices or knowledge related to the use of hearing protection equipment in the occurrence of acute acoustic trauma in a population of Army soldiers.


Condition or disease Intervention/treatment
Acoustic Trauma Other: Questionnaire

Study Design
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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Use of Hearing Protection Equipment in the Occurence of Acute Acoustic Trauma in the Army
Actual Study Start Date : March 30, 2021
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: Questionnaire
    The participants will have to fill in a questionnaire about their knowledge and their attitude regarding auditory risk.

Outcome Measures
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Primary Outcome Measures :
  1. Measurement of the importance of variables corresponding to practices or knowledge related to the use of hearing protection equipment in the occurrence of acute acoustic trauma. [ Time Frame: At enrollment ]
    The importance of variables will be measured thanks to a random forest algorithm.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The study population will be composed of male and female Army soldiers practicing shooting on a regular basis.
Criteria

Inclusion Criteria:

  • Be a member of the Army
  • Having performed at least one shooting session in the last 12 months

Exclusion Criteria:

  • Inability to read and/or write in French language
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04804982


Contacts
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Contact: Guillaume ANDEOL, MD, PhD 178651207 ext +33 guillaume.andeol@intradef.gouv.fr

Locations
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France
119e Antenne Médicale, 14e Centre Médical des Armées Recruiting
Angers, France, 49041
Contact: Jérôme WANNIN, MD    241337257 ext +33    jerome.wannin@intradef.gouv.fr   
101e Antenne Médicale, 13e Centre Médical des Armées Recruiting
Angoulême, France, 16021
Contact: Solveig COMES, MD    545648569 ext +33    solveig.comes@intradef.gouv.fr   
93e Antenne Médicale, 8e Centre Médical des Armées Recruiting
Brive-la-Gaillarde, France, 19312
Contact: Marie DELERUE, MD    587108137 ext +33    marie.delerue@intradef.gouv.fr   
Institut de Recherche Biomédicale des Armées Recruiting
Brétigny-sur-Orge, France, 91223
Contact: Guillaume ANDEOL, MD, PhD    178651207 ext +33    guillaume.andeol@intradef.gouv.fr   
176e Antenne Médicale, 11e Centre Médical des Armées Recruiting
Montauban, France, 82087
Contact: Kévin PORINO, MD    563217369 ext +33    karim.porino@intradef.gouv.fr   
31e Antenne Médicale Recruiting
Suippes, France, 51600
Contact: Delphine PAPEIX, MD    326678112 ext +33    delphine.papeix@intradef.gouv.fr   
76e Antenne Médicale, 7e Centre Médical des Armées Recruiting
Varces-Allières-et-Risset, France, 38761
Contact: Jean-Guillaume MEUSNIER, MD    456857048 ext +33    jean-guillaume.meusnier@intradef.gouv.fr   
Sponsors and Collaborators
Direction Centrale du Service de Santé des Armées
More Information
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Responsible Party: Direction Centrale du Service de Santé des Armées
ClinicalTrials.gov Identifier: NCT04804982    
Other Study ID Numbers: 2020PBMD06
2020-A03519-30 ( Other Identifier: IDRCB )
First Posted: March 18, 2021    Key Record Dates
Last Update Posted: April 2, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Loss, Noise-Induced
Wounds and Injuries
Hearing Loss, Sensorineural
Hearing Loss
Hearing Disorders
 Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases