NCT04804982

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
394

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

March 30, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2021

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

2 months

First QC Date

March 16, 2021

Last Update Submit

September 12, 2022

Conditions

Outcome Measures

Primary Outcomes (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.

    The importance of variables will be measured thanks to a random forest algorithm.

    At enrollment

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will be composed of male and female Army soldiers practicing shooting on a regular basis.

You may qualify if:

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

You may not qualify if:

  • Inability to read and/or write in French language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

119e Antenne Médicale, 14e Centre Médical des Armées

Angers, 49041, France

Location

101e Antenne Médicale, 13e Centre Médical des Armées

Angoulême, 16021, France

Location

Institut de Recherche Biomédicale des Armées

Brétigny-sur-Orge, 91223, France

Location

93e Antenne Médicale, 8e Centre Médical des Armées

Brive-la-Gaillarde, 19312, France

Location

176e Antenne Médicale, 11e Centre Médical des Armées

Montauban, 82087, France

Location

31e Antenne Médicale

Suippes, 51600, France

Location

76e Antenne Médicale, 7e Centre Médical des Armées

Varces-Allières-et-Risset, 38761, France

Location

MeSH Terms

Conditions

Hearing Loss, Noise-Induced

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Hearing Loss, SensorineuralHearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2021

First Posted

March 18, 2021

Study Start

March 30, 2021

Primary Completion

May 28, 2021

Study Completion

May 28, 2021

Last Updated

September 13, 2022

Record last verified: 2022-09

Locations