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

NCT ID: NCT04804982

Last Updated: 2022-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

394 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-30

Study Completion Date

2021-05-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acoustic Trauma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Questionnaire

The participants will have to fill in a questionnaire about their knowledge and their attitude regarding auditory risk.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Direction Centrale du Service de Santé des Armées

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

119e Antenne Médicale, 14e Centre Médical des Armées

Angers, , France

Site Status

101e Antenne Médicale, 13e Centre Médical des Armées

Angoulême, , France

Site Status

Institut de Recherche Biomédicale des Armées

Brétigny-sur-Orge, , France

Site Status

93e Antenne Médicale, 8e Centre Médical des Armées

Brive-la-Gaillarde, , France

Site Status

176e Antenne Médicale, 11e Centre Médical des Armées

Montauban, , France

Site Status

31e Antenne Médicale

Suippes, , France

Site Status

76e Antenne Médicale, 7e Centre Médical des Armées

Varces-Allières-et-Risset, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-A03519-30

Identifier Type: OTHER

Identifier Source: secondary_id

2020PBMD06

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Role of Exposure in Hyperacusis
NCT04705246 NOT_YET_RECRUITING NA
Auditory Plasticity Training
NCT06628505 RECRUITING NA
Fatigue and Hearing Loss.
NCT04875117 COMPLETED