Risk Factors for Hearing Loss as a Result of Exposure to Noise During Military Training in the IDF
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03314116|
Recruitment Status : Recruiting
First Posted : October 19, 2017
Last Update Posted : October 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hearing Loss, Noise-Induced||Other: Guidance on auditory protection||Not Applicable|
- 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 .
- If the indication obtained by the OAE device is negative, the soldier will be transferred to perform an audiometer test by a medic.
- 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).
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.
- 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,
- 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.
- 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|
|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)|
|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|
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
- 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
- Percentage of soldiers in combat units which suffer from hearing loss before starting military training [ Time Frame: 12 months ]
- 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.
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
|Contact: Sharon Ohayon Cohen, MDfirstname.lastname@example.org|
|Tel Aviv, Israel|
|Contact: Sharon Ohayon Cohen, MD +972-50-4404081 email@example.com|
|Principal Investigator:||Sharon Ohayon, MD||International Diabetes Federation|