Daily Exposure Monitoring to Prevent Hearing Loss (DEMON)

November 2, 2020 updated by: Yale University

Daily Exposure Monitoring of Noise Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

322

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale Occupational and Environmental Medicine Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

The only criterion for inclusion is that the employee is currently working in an area where there is sufficient noise exposure that the company's policy requires the use of hearing protection.

Exclusion Criteria:

There are no exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: QuietDose device VOLUNTARY
This group of employees will voluntarily use the "QuietDose" units in place of their regular hearing protection, which may be either ear plugs or ear muffs.
Device: QuietDose Device
The intervention will test the effectiveness of a noise exposure dosimeter, the QuietDose - 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.
No Intervention: No QuietDose device
This group of employees will not use the "QuietDose" units and maintain use of their regular hearing protection which may be either ear plugs or ear muffs.
Active Comparator: QuietDose Device REQUIRED
This group of employees will be required to use the "QuietDose" units in place of their regular hearing protection, which may be either ear plugs or ear muffs.
Device: QuietDose Device
The intervention will test the effectiveness of a noise exposure dosimeter, the QuietDose - 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hearing Loss
Time Frame: 1 year
Hearing loss will be measured in dB/year for the noise-sensitive audiometric frequency averages of 2, 3, and 4000 Hz and 3, 4, and 6000 Hz averaged across ears .
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Peter M Rabinowitz, MD MPH, Yale Occupational and Environmental Medicine Program: Yale University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2007

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

October 22, 2012

First Submitted That Met QC Criteria

October 22, 2012

First Posted (Estimate)

October 25, 2012

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0509000588
  • 1R01OH008641-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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