Daily Exposure Monitoring to Prevent Hearing Loss (DEMON)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Yale University
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01714375
First received: October 22, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Hearing Loss
Device: QuietDose Device
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Daily Exposure Monitoring of Noise Study

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Hearing Loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 .


Estimated Enrollment: 800
Study Start Date: July 2007
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714375

Contacts
Contact: Michael McTague 203-785-3184 michael.mctague@yale.edu

Locations
United States, Connecticut
Yale Occupational and Environmental Medicine Program Recruiting
New Haven, Connecticut, United States, 06510
Contact: Michael McTague    203-785-3184    michael.mctague@yale.edu   
Principal Investigator: Peter Rabinowitz, MD MPH         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Peter M Rabinowitz, MD MPH Yale Occupational and Environmental Medicine Program: Yale University School of Medicine
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01714375     History of Changes
Other Study ID Numbers: 0509000588, 1R01OH008641-01
Study First Received: October 22, 2012
Last Updated: October 22, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014