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

Hearing Loss, Noise-Induced Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03314116
• Other study ID #: 1796-2017
• Status: Recruiting
• Phase: N/A
• First received: September 16, 2017
• Last updated: October 28, 2017
• Start date: August 1, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: October 2017
• Source: Medical Corps, Israel Defense Force
• Contact: Sharon Ohayon Cohen, MD
• Phone: +972-50-4404081
• Email: 2sharonoh[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: August 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Noise-Induced

Intervention

Other:
• Guidance on auditory protection
by video or medic

Locations

Country	Name	City	State
Israel	IDF	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Medical Corps, Israel Defense Force

Country where clinical trial is conducted

Israel, 

References & Publications (9)

Axelsson A, Rosenhall U, Zachau G. Hearing in 18-year-old Swedish males. Scand Audiol. 1994;23(2):129-34. — View Citation

Cassano F, Aloise I, Labianca G, Gaccione V, Mazzotta C, Cardascia F, Garavaglia M, Scarselletta RS, Di Lorenzo L. [Measurement of real personal noise attenuation using earplugs with the E-A-Rfit system]. Med Lav. 2013 May-Jun;104(3):213-23. Italian. — View Citation

Gold S, Attias J, Cahani M, Shahar A. [Hearing loss as a result of basic military training]. Harefuah. 1989 Apr 2;116(7):377-9. Hebrew. — View Citation

Muchnik C, Amir N, Shabtai E, Kaplan-Neeman R. Preferred listening levels of personal listening devices in young teenagers: self reports and physical measurements. Int J Audiol. 2012 Apr;51(4):287-93. doi: 10.3109/14992027.2011.631590. Epub 2011 Nov 28. — View Citation

Muhr P, Månsson B, Hellström PA. A study of hearing changes among military conscripts in the Swedish Army. Int J Audiol. 2006 Apr;45(4):247-51. — View Citation

Murphy WJ, Themann CL, Murata TK. Hearing protector fit testing with off-shore oil-rig inspectors in Louisiana and Texas. Int J Audiol. 2016 Nov;55(11):688-98. doi: 10.1080/14992027.2016.1204470. Epub 2016 Jul 14. — View Citation

Rabinowitz PM, Slade MD, Galusha D, Dixon-Ernst C, Cullen MR. Trends in the prevalence of hearing loss among young adults entering an industrial workforce 1985 to 2004. Ear Hear. 2006 Aug;27(4):369-75. — View Citation

Toh ST, Lu P, Ong M, Seet B. Prevalence of hearing disorders in Singapore military conscripts: a role for routine audiometry screening? Singapore Med J. 2002 Dec;43(12):622-7. — View Citation

Ylikoski J. Acute acoustic trauma in Finnish conscripts. Etiological factors and characteristics of hearing impairment. Scand Audiol. 1989;18(3):161-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparative impact of military training (infantry, armor and artillery) on hearing loss after full training	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	12 months
Secondary	Percentage of soldiers in combat units which suffer from hearing loss before starting military training		12 months
Secondary	Percentage of soldiers in combat units which suffer from hearing loss after completing military training classified to the two groups in the study	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.	12 months