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

September 12, 2022 updated by: Direction Centrale du Service de Santé des Armées

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

394

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49041
        • 119e Antenne Médicale, 14e Centre Médical des Armées
      • Angoulême, France, 16021
        • 101e Antenne Médicale, 13e Centre Médical des Armées
      • Brive-la-Gaillarde, France, 19312
        • 93e Antenne Médicale, 8e Centre Médical des Armées
      • Brétigny-sur-Orge, France, 91223
        • Institut de Recherche Biomédicale des Armées
      • Montauban, France, 82087
        • 176e Antenne Médicale, 11e Centre Médical des Armées
      • Suippes, France, 51600
        • 31e Antenne Médicale
      • Varces-Allières-et-Risset, France, 38761
        • 76e Antenne Médicale, 7e Centre Médical des Armées

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Direction Centrale du Service de Santé des Armées

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2021

Primary Completion (Actual)

May 28, 2021

Study Completion (Actual)

May 28, 2021

Study Registration Dates

First Submitted

March 16, 2021

First Submitted That Met QC Criteria

March 16, 2021

First Posted (Actual)

March 18, 2021

Study Record Updates

Last Update Posted (Actual)

September 13, 2022

Last Update Submitted That Met QC Criteria

September 12, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020PBMD06
  • 2020-A03519-30 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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