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Risk Factors for Hearing Loss as a Result of Exposure to Noise During Military Training in the IDF

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ClinicalTrials.gov Identifier: NCT03314116
Recruitment Status : Recruiting
First Posted : October 19, 2017
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
Sharon Ohayon, Medical Corps, Israel Defense Force

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.

Condition or disease Intervention/treatment Phase
Hearing Loss, Noise-Induced Other: Guidance on auditory protection Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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

Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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.
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : April 1, 2018
Estimated Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: video group
guided by a 7-minute video that explains the importance of using ear plugs and correct installation.
Other: Guidance on auditory protection
by video or medic

No Intervention: control group
instructed to use earplugs properly, including practical exercises by a medic



Primary Outcome Measures :
  1. Comparative impact of military training (infantry, armor and artillery) on hearing loss after full training [ Time Frame: 12 months ]
    The study will measure hearing loss using an Oto Acoustic Emission (OAE) measuring device and an Audiometer test. The results after complete training will be compared against the results obtained prior to training


Secondary Outcome Measures :
  1. Percentage of soldiers in combat units which suffer from hearing loss before starting military training [ Time Frame: 12 months ]
  2. Percentage of soldiers in combat units which suffer from hearing loss after completing military training classified to the two groups in the study [ Time Frame: 12 months ]
    The study will investigate the effectiveness of a demonstration video as an audio protection tutorial to prevent hearing loss from exposure to noise in trained fighters. This will be measured against a control group which undergo frontal demonstration by a medic.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03314116


Contacts
Contact: Sharon Ohayon Cohen, MD +972-50-4404081 2sharonoh@gmail.com

Locations
Israel
IDF Recruiting
Tel Aviv, Israel
Contact: Sharon Ohayon Cohen, MD    +972-50-4404081    2sharonoh@gmail.com   
Sponsors and Collaborators
Medical Corps, Israel Defense Force
Investigators
Principal Investigator: Sharon Ohayon, MD International Diabetes Federation

Publications:

Responsible Party: Sharon Ohayon, Principal Investigator, Medical Corps, Israel Defense Force
ClinicalTrials.gov Identifier: NCT03314116     History of Changes
Other Study ID Numbers: 1796-2017
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sharon Ohayon, Medical Corps, Israel Defense Force:
hearing loss During basic training, otoacoustic emission

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Noise-Induced
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms