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NCT02109757 Clinical Trial

Evaluation of Hearing Protection Fit Testing Program

Hearing Loss Clinical Trial

Official title:
Evaluation of Hearing Protection Fit Testing Program

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02109757
Other study ID # FWR20130114H
Secondary ID
Status Recruiting
Phase N/A
First received January 9, 2014
Last updated April 7, 2014
Start date March 2014

Study information
Verified date April 2014
Source United States Air Force
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Other:
• Software intervention and education
Personal attenuation rating measurements will be taken before and after educating the patient using software program
• Education only

Locations
Country Name City State
United States Wright-Patterson Air Force Base Dayton Ohio
United States Elmendorf Air Force Base Elemendorf Air Force Base Alaska

Sponsors (1)
Lead Sponsor Collaborator
United States Air Force

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 6 mos after intial subject visit No
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