NCT01714375

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
322

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2012

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

11.2 years

First QC Date

October 22, 2012

Last Update Submit

November 2, 2020

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (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 .

    1 year

Study Arms (3)

QuietDose device VOLUNTARY

ACTIVE COMPARATOR

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

No QuietDose device

NO INTERVENTION

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.

QuietDose Device REQUIRED

ACTIVE COMPARATOR

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

Interventions

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.

QuietDose Device REQUIREDQuietDose device VOLUNTARY

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Occupational and Environmental Medicine Program

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

  • 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.

    PMID: 34215684DERIVED

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Peter M Rabinowitz, MD MPH

    Yale Occupational and Environmental Medicine Program: Yale University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2012

First Posted

October 25, 2012

Study Start

July 1, 2007

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

November 4, 2020

Record last verified: 2020-11

Locations

US(1)