ClinicalTrials.gg
Status unknownNCT03314116Updated Oct 31, 2017

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

An interventional study of Guidance on auditory protection in Hearing Loss, Noise-Induced, sponsored by Medical Corps, Israel Defense Force. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-31.

Sponsored by Medical Corps, Israel Defense Force · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
900
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Hearing Loss, Noise-Induced

Keywords

  • hearing loss During basic training, otoacoustic emission
03

In context

Hearing Loss, Noise-Induced

46 studies on the registry are indexed under Hearing Loss, Noise-Induced; 10 are open to participants now.

This study's planned enrollment of 900 is above the median of 88 across 30 interventional studies indexed under Hearing Loss, Noise-Induced.

Browse Hearing Loss, Noise-Induced studies →

Lead sponsor

Medical Corps, Israel Defense Force is the lead sponsor of 33 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Soldiers who joined the IDF from August 2018

Exclusion criteria

Exclusion Criteria:

  • Lack of .
  • recruits who have auditory impairment that is disqualified from fighting
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
900 participants (estimated)

Study arms

  • 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

  • No intervention
    control group

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

Interventions

  • OtherGuidance on auditory protection

    by video or medic

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 months

Secondary outcomes

  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

    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.

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • IDF
    Tel Aviv, Israel
    Recruiting
08

References and documents

Publications

  • 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. PubMed 22122401 ↗
  • 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. PubMed 16825886 ↗
  • 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. PubMed 16684706 ↗
  • 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. PubMed 12693766 ↗
  • Axelsson A, Rosenhall U, Zachau G. Hearing in 18-year-old Swedish males. Scand Audiol. 1994;23(2):129-34. doi: 10.3109/01050399409047497. PubMed 8085113 ↗
  • 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. PubMed 2737562 ↗
  • 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. PubMed 2814330 ↗
  • 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. PubMed 27414471 ↗
  • 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. PubMed 23879065 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2017 (actual). Primary completion is estimated for Apr 2018, 8 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 16, 2017
First posted
Oct 19, 2017
StartActual
Aug 1, 2017
Primary completionEst.
Apr 1, 2018
CompletionEst.
Aug 1, 2018
Last update
Oct 31, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03314116
Lead sponsor
Medical Corps, Israel Defense Force
Responsible party
Sharon Ohayon (Principal Investigator, Medical Corps, Israel Defense Force) — Principal investigator
First posted
Oct 19, 2017
Start date
Aug 1, 2017
Primary completion
Apr 1, 2018 (estimated)
Completion
Aug 1, 2018 (estimated)
Last update
Oct 31, 2017

Study contacts

Sharon Ohayon Cohen, MD
Contact
2sharonoh@gmail.com
+972-50-4404081
Sharon Ohayon, MD
principal investigator · International Diabetes Federation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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