NCT03314116

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

October 31, 2017

Status Verified

October 1, 2017

Enrollment Period

8 months

First QC Date

September 16, 2017

Last Update Submit

October 28, 2017

Conditions

Keywords

hearing loss During basic training, otoacoustic emission

Outcome Measures

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

    12 months

Secondary Outcomes (2)

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

    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

    12 months

Study Arms (2)

video group

EXPERIMENTAL

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

Other: Guidance on auditory protection

control group

NO INTERVENTION

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

Interventions

by video or medic

video group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Soldiers who joined the IDF from August 2018

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IDF

Tel Aviv, Israel

RECRUITING

Related Publications (9)

  • 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.

    PMID: 22122401BACKGROUND
  • 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.

    PMID: 16825886BACKGROUND
  • 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.

    PMID: 16684706BACKGROUND
  • 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.

    PMID: 12693766BACKGROUND
  • Axelsson A, Rosenhall U, Zachau G. Hearing in 18-year-old Swedish males. Scand Audiol. 1994;23(2):129-34. doi: 10.3109/01050399409047497.

    PMID: 8085113BACKGROUND
  • 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.

    PMID: 2737562BACKGROUND
  • 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.

    PMID: 2814330BACKGROUND
  • 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.

    PMID: 27414471BACKGROUND
  • 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.

    PMID: 23879065BACKGROUND

MeSH Terms

Conditions

Hearing Loss, Noise-Induced

Condition Hierarchy (Ancestors)

Hearing Loss, SensorineuralHearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sharon Ohayon, MD

    International Diabetes Federation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon Ohayon Cohen, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 16, 2017

First Posted

October 19, 2017

Study Start

August 1, 2017

Primary Completion

April 1, 2018

Study Completion

August 1, 2018

Last Updated

October 31, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations