Evaluation of Hearing Protection Fit Testing Program

April 7, 2014 updated by: Quintin Hecht, United States Air Force
The specific aim of this research is to evaluate the performance, effectiveness, and long-term training benefits of a formal hearing protection fit testing program. This study may provide preliminary evidence on the benefits of direct education/training combined with a formal hearing protection device (HPD) fit testing on HPD fittings on United States Air Force (USAF) employees. Currently, Public Health provides informal, subjective training to employees; this practice may be altered by the results of this study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

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
    • Alaska
      • Elemendorf Air Force Base, Alaska, United States
        • Recruiting
        • Elmendorf Air Force Base
        • Contact:
        • Principal Investigator:
          • Shannon Hunt, Au.D.
        • Sub-Investigator:
          • Daniel Williams, Au.D.
    • Ohio
      • Dayton, Ohio, United States, 45433
        • Recruiting
        • Wright-Patterson Air Force Base
        • Contact:
        • Principal Investigator:
          • Quintin A Hecht, Au.D.
        • Sub-Investigator:
          • Elizabeth A McKenna, Au.D.
        • Sub-Investigator:
          • April Taylor, Au.D.
        • Sub-Investigator:
          • Malisha Martukovich, Au.D.
        • Sub-Investigator:
          • Matthew Williams, Au.D.
        • Sub-Investigator:
          • Katie Tastad, MPH
        • Sub-Investigator:
          • Christina Waldrop, Associates
        • Sub-Investigator:
          • Michelle LeMond, Associates

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must be enrolled in the hearing conservation program, and can be civilian or active duty/uniformed. Subjects must be currently using some form of in-the-ear hearing protection device on a regular basis and have ear canals free of cerumen, infection, or any other obstruction.

Exclusion Criteria:

  • Not enrolled in the hearing conservation program. Not using in-the-ear hearing protection device on a regular basis. Ear canals containing cerumen, infection, or other obstructions.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Software intervention and education
This group will receive software intervention and education before and after receiving one-on-one education, thus showing if benefit or effect occurs simply due to having the software input before receiving education.
Other: Software intervention and education
Personal attenuation rating measurements will be taken before and after educating the patient using software program
Active Comparator: Education only
This group will not receive software intervention prior to and after one-on-one education, only afterwards.
Other: Education only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of earplug fit for participants in the Air Force Hearing Conservation Program as a measure of education and personnal attenuation rating.
Time Frame: 6 mos after intial subject visit
The experimental group will show an increase, larger than the control group, in the amount of personal attenuation rating measurement shown by the software program as a result of software intervention used before and after education at the initial and follow-up visits.
6 mos after intial subject visit

Collaborators and Investigators

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

Sponsor

United States Air Force

Investigators

  • Principal Investigator: Quintin A Hecht, Au.D., United States Air Force School of Aerospace Medicine

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

March 1, 2014

Primary Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

January 9, 2014

First Submitted That Met QC Criteria

April 7, 2014

First Posted (Estimate)

April 10, 2014

Study Record Updates

Last Update Posted (Estimate)

April 10, 2014

Last Update Submitted That Met QC Criteria

April 7, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FWR20130114H

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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