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Hearing LossDEMONNCT01714375

Daily Exposure Monitoring to Prevent Hearing Loss

A study testing QuietDose Device in people with Hearing Loss, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hearing Loss
What is being tested?
QuietDose Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
322 participants
Where
1 siteUnited States
Study dates
1 Jul 2007to 1 Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • There are no exclusion criteria.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Yale Occupational and Environmental Medicine Program

    New Haven, Connecticut, 06510

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Hearing Loss
Being tested
QuietDose Device
Medical subject headings
Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuietDose DeviceDevice

    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.

Study groups in NCT01714375
Study groupRoleWhat they receive
QuietDose device VOLUNTARYActive comparatorThis 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.
Receives: Device: QuietDose Device
No QuietDose deviceNo interventionThis 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.
QuietDose Device REQUIREDActive comparatorThis 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.
Receives: Device: QuietDose Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hearing Loss

    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 .

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2012 (estimated)
  2. Study start1 Jul 2007
  3. Primary completion1 Sep 2018
  4. Study completion1 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
322 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01714375
Sponsor's protocol ID
0509000588
Other IDs
1R01OH008641-01
Acronym
DEMON
Status last verified
Nov 2020
First submitted
22 Oct 2012
Last updated
4 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Rabinowitz P, Galusha D, Cantley LF, Dixon-Ernst C, Neitzel R. Feasibility of a daily noise monitoring intervention for prevention of noise-induced hearing loss. Occup Environ Med. 2021 Nov;78(11):835-840. doi: 10.1136/oemed-2020-107351. Epub 2021 Jul 2.

    PubMed 34215684

Questions about this trial

What is this clinical trial studying?

A study testing QuietDose Device in people with Hearing Loss, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hearing Loss (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01714375, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.

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