Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01714375 |
| Other study ID # |
0509000588 |
| Secondary ID |
1R01OH008641-01 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2007 |
| Est. completion date |
September 1, 2018 |
Study information
| Verified date |
November 2020 |
| Source |
Yale University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this study is to determine whether daily assessment and feedback of workers'
noise exposures leads to more effective use of hearing protection and prevention of
noise-induced hearing loss.
Description:
Despite the existence of an OSHA standard for hearing conservation, noise-induced hearing
loss continues to be one of the most prevalent occupational conditions. Furthermore, hearing
loss rates appear to vary significantly between industrial locations with similar measured
noise exposure levels. The factors that determine an effective hearing conservation program
remain poorly understood. The effective use of hearing protection, believed to be a critical
component of such programs, is felt to be highly variable in real world situations.
Provocative new data by our research group indicate that much of the preventable hearing loss
in a large industrial workforce is occurring not among the workers in the highest ambient
noise areas, but instead among employees working in areas where measured ambient median noise
exposures are close to or even slightly below the current OSHA action level (85dBA for an 8
hour time weighted average). One possible reason could be that the use of hearing protection
is currently less effective in such areas of lower or intermittent noise compared to high
noise areas. Since in many worksites, the majority of workers are exposed to moderate noise
levels, there is an urgent need to better understand how to prevent hearing loss in these
settings. There are also currently no national guidelines for ensuring correct fit and
function of hearing protection, and there is an urgent need to find ways to promote the
correct use of hearing protective devices. This study will assess the impact of hearing
protector fit testing and daily noise exposure monitoring, with major implications for
hearing conservation practice, and the wider prevention of noise-induced hearing loss. It
will also explore the role of hearing protective devices in areas of median noise exposure
less than 85dBA.
This proposed study is a worksite intervention trial of a new technology to reduce
occupational noise-induced hearing loss. The intervention will test the effectiveness of a
noise exposure dosimeter, the QuietDose - essentially a small microphone connected to a noise
logging device about the size of a beeper- that measures a worker's daily noise "dose", as
well as peak noise exposure, inside of the worker's hearing protectors. Workers and the study
coordinator receive daily feedback about noise exposures (if the device was used outside of
the study it would be safety personnel that received the feedback outside of the workers
themselves). Such feedback will allow steps to be taken to minimize such exposures, such as
behavioral adjustments and improved awarenessThe goal of this study is to determine whether
daily assessment and feedback of workers' noise exposures leads to more effective use of
hearing protection and prevention of noise-induced hearing loss. The proposed study will take
advantage of the unique working relationship between a research institution (the Yale
Occupational and Environmental Medicine Program) and a major industrial corporation (Alcoa,
Inc.) to conduct this intervention trial at several of the company's facilities.
