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Evaluation of Hearing Protection Fit Testing Program

Primary Purpose

Hearing Loss

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Software intervention and education
Education only
Sponsored by
United States Air Force
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hearing Loss focused on measuring Hearing conservation, Personal attenuation rating, earplug

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Elmendorf Air Force BaseRecruiting
  • Wright-Patterson Air Force BaseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Software intervention and education

Education only

Arm Description

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.

This group will not receive software intervention prior to and after one-on-one education, only afterwards.

Outcomes

Primary Outcome Measures

Degree of earplug fit for participants in the Air Force Hearing Conservation Program as a measure of education and personnal attenuation rating.
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.

Secondary Outcome Measures

Full Information

First Posted
January 9, 2014
Last Updated
April 7, 2014
Sponsor
United States Air Force
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1. Study Identification

Unique Protocol Identification Number
NCT02109757
Brief Title
Evaluation of Hearing Protection Fit Testing Program
Official Title
Evaluation of Hearing Protection Fit Testing Program
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United States Air Force

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Hearing conservation, Personal attenuation rating, earplug

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Software intervention and education
Arm Type
Experimental
Arm Description
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.
Arm Title
Education only
Arm Type
Active Comparator
Arm Description
This group will not receive software intervention prior to and after one-on-one education, only afterwards.
Intervention Type
Other
Intervention Name(s)
Software intervention and education
Intervention Description
Personal attenuation rating measurements will be taken before and after educating the patient using software program
Intervention Type
Other
Intervention Name(s)
Education only
Primary Outcome Measure Information:
Title
Degree of earplug fit for participants in the Air Force Hearing Conservation Program as a measure of education and personnal attenuation rating.
Description
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.
Time Frame
6 mos after intial subject visit

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quintin A Hecht, Au.D.
Organizational Affiliation
United States Air Force School of Aerospace Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Elmendorf Air Force Base
City
Elemendorf Air Force Base
State/Province
Alaska
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon Hunt, Au.D.
Phone
907-580-5804
Email
shannon.hunt.3@us.af.mil
First Name & Middle Initial & Last Name & Degree
Shannon Hunt, Au.D.
First Name & Middle Initial & Last Name & Degree
Daniel Williams, Au.D.
Facility Name
Wright-Patterson Air Force Base
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45433
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quintin A Hecht, Au.D.
Phone
937-938-3201
Email
quintin.hecht.1@us.af.mil
First Name & Middle Initial & Last Name & Degree
Quintin A Hecht, Au.D.
First Name & Middle Initial & Last Name & Degree
Elizabeth A McKenna, Au.D.
First Name & Middle Initial & Last Name & Degree
April Taylor, Au.D.
First Name & Middle Initial & Last Name & Degree
Malisha Martukovich, Au.D.
First Name & Middle Initial & Last Name & Degree
Matthew Williams, Au.D.
First Name & Middle Initial & Last Name & Degree
Katie Tastad, MPH
First Name & Middle Initial & Last Name & Degree
Christina Waldrop, Associates
First Name & Middle Initial & Last Name & Degree
Michelle LeMond, Associates

12. IPD Sharing Statement

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Evaluation of Hearing Protection Fit Testing Program

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