NCT02109757

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.

Trial Health

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Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 10, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Last Updated

April 10, 2014

Status Verified

April 1, 2014

Enrollment Period

1.6 years

First QC Date

January 9, 2014

Last Update Submit

April 7, 2014

Conditions

Keywords

Hearing conservationPersonal attenuation ratingearplug

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Software intervention and education

EXPERIMENTAL

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

Education only

ACTIVE COMPARATOR

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

Other: Education only

Interventions

Personal attenuation rating measurements will be taken before and after educating the patient using software program

Software intervention and education
Education only

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Elmendorf Air Force Base

Elemendorf Air Force Base, Alaska, United States

RECRUITING

Wright-Patterson Air Force Base

Dayton, Ohio, 45433, United States

RECRUITING

MeSH Terms

Conditions

Hearing Loss

Interventions

Educational Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Quintin A Hecht, Au.D.

    United States Air Force School of Aerospace Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hearing Conservation Program Manager, Doctor of Audiology

Study Record Dates

First Submitted

January 9, 2014

First Posted

April 10, 2014

Study Start

March 1, 2014

Primary Completion

October 1, 2015

Last Updated

April 10, 2014

Record last verified: 2014-04

Locations