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Central Auditory Processing Disorders Associated With Blast Exposure

Primary Purpose

Central Auditory Processing Disorder, Traumatic Brain Injury, Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Audiological testing
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Central Auditory Processing Disorder focused on measuring Central Auditory Processing, Traumatic Brain Injury, Hearing Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Experimental group:

  • Active duty soldier at Walter Reed Army Medical Center, Washington DC
  • a notation in medical record of exposure to blast
  • a Glasgow Coma Scale of 13-15, indicating mild or no traumatic brain injury (TBI
  • cognitive and physical ability to take part in these auditory evaluations.
  • Age 18 years or older
  • native speaker of English (since test materials are presented in English)

Control group:

  • able to commute to Portland (Oregon)VA Med Ctr.
  • no exposure to blast
  • cognitive and physical ability to take part in these auditory evaluations.
  • age 18 years or older
  • native speaker of English

Exclusion Criteria:

  • hearing loss greater than 50 dB HL three-frequency pure tone average bilaterally

Sites / Locations

  • Walter Reed Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Blast

Control

Arm Description

The study group includes soldiers who have recently been exposed to a high-explosive blast while stationed in Iraq or Afghanistan. They will be recruited at Walter Reed Army Medical Center, Washington, DC. They will undergo audiological testing.

Control group are subjects matched to the experimental group by age, gender, and hearing loss, but who have not been exposed to a blast. They will undergo the same audiological testing as the experimental group

Outcomes

Primary Outcome Measures

Audiological Test Results
Audiometric testing, with normal hearing specified as better (lower) than 25 decibels Hearing Level (dBHL), and a mild hearing loss between 25 to 50 dBHL.

Secondary Outcome Measures

Quality of Life Questionnaire
Self-report questionnaires regarding quality of life

Full Information

First Posted
November 5, 2007
Last Updated
July 12, 2018
Sponsor
VA Office of Research and Development
Collaborators
Walter Reed Army Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00554801
Brief Title
Central Auditory Processing Disorders Associated With Blast Exposure
Official Title
Central Auditory Processing Disorders Associated With Blast Exposure
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Walter Reed Army Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The incidence of central auditory dysfunction in war fighters who are exposed to high-explosive blasts while serving in combat have not been clearly determined. The objectives of this study are to determine whether central auditory processing (CAP) disorders are associated with exposure to high-explosive blasts. This study will also examine the incidence, magnitude and timing of spontaneous recovery of CAP function from blast exposure. The information provided by this study will help guide clinicians in both the military and VA health care systems regarding the likelihood of central auditory processing disorders in soldiers returning from deployment and suggest some clinical rehabilitative strategies for the treatment of these patients with CAP deficits.
Detailed Description
The incidence and nature of central auditory dysfunction in combat soldiers who are exposed to high-explosive blasts have not been determined. Using a battery of behavioral and neurophysiological auditory tests, we propose to evaluate central auditory function in soldiers who recently have been exposed to explosive blasts while deployed in Iraq or Afghanistan. In collaboration with the Army Audiology & Speech Center at Walter Reed Army Medical Center (WRAMC), the research will be coordinated at the National Center for Rehabilitative Auditory Research (NCRAR) at the Portland VA Medical Center, and data collection will take place both at the NCRAR and at WRAMC. The study objectives are to determine if specific central auditory processing disorders are often associated with exposure to high-explosive blasts, and if these disorders spontaneously recover or remain over time. One hundred patients who have suffered a blast exposure, but have either no brain damage or mild traumatic brain injury (TBI), will be recruited at WRAMC to participate in this research study. A battery of central auditory processing tests will be administered to participants as soon as possible after their arrival at WRAMC. Patients who demonstrate aspects of central auditory processing disorder will be invited to participate in further testing nine to twelve months later. Those subjects will be brought to the NCRAR at the Portland VA Medical Center or will return to WRAMC for two days of auditory testing, where they will undergo the same battery of tests administered initially. Control subjects who do not have a history of blast exposure and who are matched in age, gender, and audiometric configuration with the experimental subjects will also be tested at the NCRAR site. Data extracted by interview and from medical records, including details of the blast exposure, scores on overall tests of brain function administered by the WRAMC TBI team, presence or absence of post traumatic stress disorder, as well as self-report questionnaires regarding quality of life, presence of tinnitus and/or balance problems, will be used in the interpretation of results.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Auditory Processing Disorder, Traumatic Brain Injury, Hearing Loss
Keywords
Central Auditory Processing, Traumatic Brain Injury, Hearing Loss

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blast
Arm Type
Experimental
Arm Description
The study group includes soldiers who have recently been exposed to a high-explosive blast while stationed in Iraq or Afghanistan. They will be recruited at Walter Reed Army Medical Center, Washington, DC. They will undergo audiological testing.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control group are subjects matched to the experimental group by age, gender, and hearing loss, but who have not been exposed to a blast. They will undergo the same audiological testing as the experimental group
Intervention Type
Procedure
Intervention Name(s)
Audiological testing
Intervention Description
Subjects will take part in a battery of audiological tests meant to evaluate the function and status of the auditory system. These tests are similar to the kinds of testing carried out routinely in audiology clinics, and include behavioral tests of pure tone hearing, speech perception, and central auditory function, and electrophysiological testing of the middle ear and of the central auditory system.
Primary Outcome Measure Information:
Title
Audiological Test Results
Description
Audiometric testing, with normal hearing specified as better (lower) than 25 decibels Hearing Level (dBHL), and a mild hearing loss between 25 to 50 dBHL.
Time Frame
three years
Secondary Outcome Measure Information:
Title
Quality of Life Questionnaire
Description
Self-report questionnaires regarding quality of life
Time Frame
Three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Experimental group: Active duty soldier at Walter Reed Army Medical Center, Washington DC a notation in medical record of exposure to blast a Glasgow Coma Scale of 13-15, indicating mild or no traumatic brain injury (TBI cognitive and physical ability to take part in these auditory evaluations. Age 18 years or older native speaker of English (since test materials are presented in English) Control group: able to commute to Portland (Oregon)VA Med Ctr. no exposure to blast cognitive and physical ability to take part in these auditory evaluations. age 18 years or older native speaker of English Exclusion Criteria: hearing loss greater than 50 dB HL three-frequency pure tone average bilaterally
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marjorie R. Leek, PhD
Organizational Affiliation
VA Loma Linda Healthcare System, Loma Linda, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23341279
Citation
Gallun FJ, Lewis MS, Folmer RL, Diedesch AC, Kubli LR, McDermott DJ, Walden TC, Fausti SA, Lew HL, Leek MR. Implications of blast exposure for central auditory function: a review. J Rehabil Res Dev. 2012;49(7):1059-74. doi: 10.1682/jrrd.2010.09.0166.
Results Reference
background
PubMed Identifier
23341276
Citation
Gallun FJ, Diedesch AC, Kubli LR, Walden TC, Folmer RL, Lewis MS, McDermott DJ, Fausti SA, Leek MR. Performance on tests of central auditory processing by individuals exposed to high-intensity blasts. J Rehabil Res Dev. 2012;49(7):1005-25. doi: 10.1682/jrrd.2012.03.0038.
Results Reference
result
Links:
URL
http://www.asha.org
Description
Web site of the American Speech-Language Hearing Association
URL
http://www.dvbic.org
Description
web site of Defense and Veterans Brain Injury Center

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Central Auditory Processing Disorders Associated With Blast Exposure

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