Clinical trial NCT03314116: Risk Factors for Hearing Loss as a Result of Exposure to Noise During Military Training in the IDF
Official title: Assessment of Risk Factors for Hearing Loss as a Result of Exposure to Noise During Military Training in the IDF (Israel Defense Forces), and Examination of the Effectiveness of Hearing Protection Video vs Formal Training.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hearing Loss, Noise-Induced
Keywords: hearing loss During basic training, otoacoustic emission
Lead sponsor: Medical Corps, Israel Defense Force
Sponsor class: OTHER
First posted: 2017-10-19
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants will be randomly assigned to two groups:

The video group will be guided by a 7-minute video that explains the importance of using ear plugs and correct installation.

The control group, will be instructed to use earplugs properly, including practical exercises by a medic
Primary purpose: PREVENTION

Brief summary: As part of the proposed work, the investigators would like to examine whether there is a need to use a training video to train IDF combat soldiers to improve the use of ear plugs and to prevent hearing loss from exposure to noise, and to characterize the hearing impaired epidemiology of recruits and the basic rate of hearing loss During basic training.

Detailed description: 1. Auditory screening examination using an OAE (Oto Acoustic Emission) device during the first week of training in the unit and before starting to be exposed to noise .
2. If the indication obtained by the OAE device is negative, the soldier will be transferred to perform an audiometer test by a medic.
3. If the audiometer is subjected to a significant drop (over 25 decibels), the soldier will be referred to an audiologic examination that includes a comprehensive hearing test and an examination by the ENT (Ear, Nose and Throat).
4. All participants will be randomly assigned to two groups after signing an agreement form:

   A - The video group - will be guided by a screening of a 7 minute video that explains the importance of using ear plugs and correct installation.

   B- The control group, will be instructed to use earplugs properly, including practical exercises by a medic.
5. After two months of training, all participants will undergo further instruction in the use of earplugs, the video clip group and the control group trained by a medic only,
6. Towards the end of the training After six months of the recruitment, the investigators will perform an additional hearing test for all the participants in order to compare the results to the examination performed near their recruitment. Similar to the first stage, the test will be performed using an OAE device.
7. A comparison shall be made in the auditory results data between the group that underwent training via video and the control group.

Eligibility criteria: Inclusion Criteria:

* Soldiers who joined the IDF from August 2018

Exclusion Criteria:

* Lack of informed consent.
* recruits who have auditory impairment that is disqualified from fighting

Primary outcomes:
measure: Comparative impact of military training (infantry, armor and artillery) on hearing loss after full training
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of soldiers in combat units which suffer from hearing loss before starting military training
timeFrame: 12 months
measure: Percentage of soldiers in combat units which suffer from hearing loss after completing military training classified to the two groups in the study
timeFrame: 12 months
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: IDF
Study officials:
affiliation: International Diabetes Federation
name: Sharon Ohayon, MD
role: PRINCIPAL_INVESTIGATOR
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