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Hearing Loss, Noise-InducedNCT03314116

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

A study testing Guidance on auditory protection in people with Hearing Loss, Noise-Induced, run by Medical Corps, Israel Defense Force at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hearing Loss, Noise-Induced
What is being tested?
Guidance on auditory protection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
1 siteIsrael
Study dates
1 Aug 2017to 1 Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Soldiers who joined the IDF from August 2018

Who cannot join

  • Lack of informed consent.
  • recruits who have auditory impairment that is disqualified from fighting

Trial locations and contacts

1 site in 1 country.

Sharon Ohayon Cohen, MD contact

+972-50-4404081

2sharonoh@gmail.com

Israel1 site, 1 recruiting

  • IDF

    Tel Aviv

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

    Recruiting

Other trials in Israel

About this study

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.

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.
Being tested
Guidance on auditory protection
Keywords
hearing loss During basic training, otoacoustic emission
Medical subject headings
Hearing Loss, Noise-Induced

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Guidance on auditory protectionOther

    by video or medic

Study groups in NCT03314116
Study groupRoleWhat they receive
video groupExperimentalguided by a 7-minute video that explains the importance of using ear plugs and correct installation.
Receives: Other: Guidance on auditory protection
control groupNo interventioninstructed to use earplugs properly, including practical exercises by a medic

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (2)

  1. Percentage of soldiers in combat units which suffer from hearing loss before starting military training

    Measured: 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2017
  2. Study start1 Aug 2017
  3. Primary completion1 Apr 2018 (estimated)
  4. Study completion1 Aug 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Outcomes assessor
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03314116
Sponsor's protocol ID
1796-2017
Status last verified
Oct 2017
First submitted
16 Sep 2017
Last updated
31 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Guidance on auditory protection in people with Hearing Loss, Noise-Induced, run by Medical Corps, Israel Defense Force at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sharon Ohayon Cohen, MD (+972-50-4404081, 2sharonoh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparative impact of military training (infantry, armor and artillery) on hearing loss after full training (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03314116, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2017.

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