Risk Factors for Hearing Loss as a Result of Exposure to Noise During Military Training in the IDF
Primary Purpose
Hearing Loss, Noise-Induced
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Guidance on auditory protection
Sponsored by
About this trial
This is an interventional prevention trial for Hearing Loss, Noise-Induced focused on measuring hearing loss During basic training, otoacoustic emission
Eligibility Criteria
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
Sites / Locations
- IDFRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
video group
control group
Arm Description
guided by a 7-minute video that explains the importance of using ear plugs and correct installation.
instructed to use earplugs properly, including practical exercises by a medic
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Percentage of soldiers in combat units which suffer from hearing loss before starting military training
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.
Full Information
NCT ID
NCT03314116
First Posted
September 16, 2017
Last Updated
October 28, 2017
Sponsor
Medical Corps, Israel Defense Force
1. Study Identification
Unique Protocol Identification Number
NCT03314116
Brief Title
Risk Factors for Hearing Loss as a Result of Exposure to Noise During Military Training in the IDF
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
April 1, 2018 (Anticipated)
Study Completion Date
August 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical Corps, Israel Defense Force
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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 .
If the indication obtained by the OAE device is negative, the soldier will be transferred to perform an audiometer test by a medic.
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).
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.
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,
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.
A comparison shall be made in the auditory results data between the group that underwent training via video and the control group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Noise-Induced
Keywords
hearing loss During basic training, otoacoustic emission
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
900 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
video group
Arm Type
Experimental
Arm Description
guided by a 7-minute video that explains the importance of using ear plugs and correct installation.
Arm Title
control group
Arm Type
No Intervention
Arm Description
instructed to use earplugs properly, including practical exercises by a medic
Intervention Type
Other
Intervention Name(s)
Guidance on auditory protection
Intervention Description
by video or medic
Primary Outcome Measure Information:
Title
Comparative impact of military training (infantry, armor and artillery) on hearing loss after full training
Description
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 Outcome Measure Information:
Title
Percentage of soldiers in combat units which suffer from hearing loss before starting military training
Time Frame
12 months
Title
Percentage of soldiers in combat units which suffer from hearing loss after completing military training classified to the two groups in the study
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon Ohayon Cohen, MD
Phone
+972-50-4404081
Email
2sharonoh@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Ohayon, MD
Organizational Affiliation
International Diabetes Federation
Official's Role
Principal Investigator
Facility Information:
Facility Name
IDF
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Ohayon Cohen, MD
Phone
+972-50-4404081
Email
2sharonoh@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22122401
Citation
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Results Reference
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PubMed Identifier
16825886
Citation
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Results Reference
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PubMed Identifier
16684706
Citation
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Results Reference
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PubMed Identifier
12693766
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.
Results Reference
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PubMed Identifier
8085113
Citation
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Results Reference
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PubMed Identifier
2737562
Citation
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Results Reference
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PubMed Identifier
2814330
Citation
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Results Reference
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PubMed Identifier
27414471
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.
Results Reference
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PubMed Identifier
23879065
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.
Results Reference
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Risk Factors for Hearing Loss as a Result of Exposure to Noise During Military Training in the IDF
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