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临床试验/NCT03314116
NCT03314116Unknown不适用

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.

Medical Corps, Israel Defense Force1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2017年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
900
试验地点
1
主要终点
Comparative impact of military training (infantry, armor and artillery) on hearing loss after full training

研究概览

简要总结

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.

详细描述

  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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Soldiers who joined the IDF from August 2018

排除标准

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

研究组 & 干预措施

video group

Experimental

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

干预措施: Guidance on auditory protection (Other)

control group

No Intervention

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

结局指标

主要结局

Comparative impact of military training (infantry, armor and artillery) on hearing loss after full training

时间窗: 12 months

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

次要结局

  • 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)
  • Percentage of soldiers in combat units which suffer from hearing loss before starting military training(12 months)

研究者

发起方
Medical Corps, Israel Defense Force
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sharon Ohayon

Principal Investigator

Medical Corps, Israel Defense Force

研究点 (1)

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