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

NCT ID: NCT03314116

Last Updated: 2017-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-08-01

Brief Summary

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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

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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.

Conditions

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Hearing Loss, Noise-Induced

Keywords

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hearing loss During basic training, otoacoustic emission

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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video group

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

Group Type EXPERIMENTAL

Guidance on auditory protection

Intervention Type OTHER

by video or medic

control group

instructed to use earplugs properly, including practical exercises by a medic

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Guidance on auditory protection

by video or medic

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical Corps, Israel Defense Force

OTHER

Sponsor Role lead

Responsible Party

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Sharon Ohayon

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sharon Ohayon, MD

Role: PRINCIPAL_INVESTIGATOR

International Diabetes Federation

Locations

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IDF

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Sharon Ohayon Cohen, MD

Role: CONTACT

Phone: +972-50-4404081

Email: [email protected]

Facility Contacts

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Sharon Ohayon Cohen, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 22122401 (View on PubMed)

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. doi: 10.1097/01.aud.0000224125.12338.9a.

Reference Type BACKGROUND
PMID: 16825886 (View on PubMed)

Muhr P, Mansson B, Hellstrom PA. A study of hearing changes among military conscripts in the Swedish Army. Int J Audiol. 2006 Apr;45(4):247-51. doi: 10.1080/14992020500190052.

Reference Type BACKGROUND
PMID: 16684706 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12693766 (View on PubMed)

Axelsson A, Rosenhall U, Zachau G. Hearing in 18-year-old Swedish males. Scand Audiol. 1994;23(2):129-34. doi: 10.3109/01050399409047497.

Reference Type BACKGROUND
PMID: 8085113 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2737562 (View on PubMed)

Ylikoski J. Acute acoustic trauma in Finnish conscripts. Etiological factors and characteristics of hearing impairment. Scand Audiol. 1989;18(3):161-5. doi: 10.3109/01050398909070741.

Reference Type BACKGROUND
PMID: 2814330 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27414471 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23879065 (View on PubMed)

Other Identifiers

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1796-2017

Identifier Type: -

Identifier Source: org_study_id