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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04804982
Other study ID # 2020PBMD06
Secondary ID 2020-A03519-30
Status Completed
Phase
First received
Last updated
Start date March 30, 2021
Est. completion date May 28, 2021

Study information

Verified date September 2022
Source Direction Centrale du Service de Santé des Armées
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 394
Est. completion date May 28, 2021
Est. primary completion date May 28, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
France 119e Antenne Médicale, 14e Centre Médical des Armées Angers
France 101e Antenne Médicale, 13e Centre Médical des Armées Angoulême
France Institut de Recherche Biomédicale des Armées Brétigny-sur-Orge
France 93e Antenne Médicale, 8e Centre Médical des Armées Brive-la-Gaillarde
France 176e Antenne Médicale, 11e Centre Médical des Armées Montauban
France 31e Antenne Médicale Suippes
France 76e Antenne Médicale, 7e Centre Médical des Armées Varces-Allières-et-Risset

Sponsors (1)

Lead Sponsor Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT04832230 - Study of Diagnostic Biomarkers of Acute Acoustic Trauma