Acoustic TraumaQPROTECNCT04804982
Study of the Use of Hearing Protection Equipment in the Occurence of Acute Acoustic Trauma in the Army
An observational study of Acoustic Trauma, run by Direction Centrale du Service de Santé des Armées at 7 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acoustic Trauma
- What is being tested?
- Questionnaire
- How many people
- 394 participants
- Where
- 7 sitesFrance
- Study dates
- 30 Mar 2021to 28 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population will be composed of male and female Army soldiers practicing shooting on a regular basis.
Who may be able to join
- Be a member of the Army
- Having performed at least one shooting session in the last 12 months
Who cannot join
- Inability to read and/or write in French language
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
119e Antenne Médicale, 14e Centre Médical des Armées
Angers, 49041
101e Antenne Médicale, 13e Centre Médical des Armées
Angoulême, 16021
Institut de Recherche Biomédicale des Armées
Brétigny-sur-Orge, 91223
93e Antenne Médicale, 8e Centre Médical des Armées
Brive-la-Gaillarde, 19312
176e Antenne Médicale, 11e Centre Médical des Armées
Montauban, 82087
31e Antenne Médicale
Suippes, 51600
76e Antenne Médicale, 7e Centre Médical des Armées
Varces-Allières-et-Risset, 38761
About this study
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.
- Conditions
- Acoustic Trauma
- Being tested
- Questionnaire
- Medical subject headings
- Hearing Loss, Noise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
The participants will have to fill in a questionnaire about their knowledge and their attitude regarding auditory risk.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start30 Mar 2021
- Primary completion28 May 2021
- Study completion28 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acoustic TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804982
- Sponsor's protocol ID
- 2020PBMD06
- Other IDs
- 2020-A03519-30
- Acronym
- QPROTEC
- Status last verified
- Sep 2022
- First submitted
- 16 Mar 2021
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Use of Hearing Protection Equipment in the Occurence of Acute Acoustic Trauma in the Army
- ClinicalTrials.gov ID
- NCT04804982
- Acronym / sponsor ID
- QPROTEC / 2020PBMD06
- Conditions
- Acoustic Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will be composed of male and female Army soldiers practicing shooting on a regular basis.
Key inclusion criteria (2 listed)
- Be a member of the Army
- Having performed at least one shooting session in the last 12 months
Key exclusion criteria (1 listed)
- Inability to read and/or write in French language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireThe participants will have to fill in a questionnaire about their knowledge and their attitude regarding auditory risk. | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acoustic Trauma, run by Direction Centrale du Service de Santé des Armées at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.