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Central Auditory Processing Disorders Associated With Blast Exposure
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, September 2008
Sponsors and Collaborators: Department of Veterans Affairs
Walter Reed Army Medical Center
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00554801
  Purpose

The incidence of central auditory dysfunction in warfighters 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.


Condition Intervention
Central Auditory Processing Disorder
Traumatic Brain Injury
Hearing Loss
Procedure: Audiological testing

Genetics Home Reference related topics: nonsyndromic deafness
MedlinePlus related topics: Hearing Disorders and Deafness Traumatic Brain Injury
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Bio-equivalence Study
Official Title: Central Auditory Processing Disorders Associated With Blast Exposure

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Audiological Test Results [ Time Frame: three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • questionaires regarding quality of life [ Time Frame: three years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2007
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
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.
Procedure: Audiological testing
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.

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, a well as self-report questionnaires regarding quality of life, presence of tinnitus and/or balance problems, will be used in the interpretation of results.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 Glascow 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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554801

Contacts
Contact: Marjorie R Leek, PhD (503) 220-8262 marjorie.leek@va.gov
Contact: Anna Diedesch (503) 220-8262 ext 51934 Anna.Diedesch2@va.gov

Locations
United States, District of Columbia
Walter Reed Army Medical Center Not yet recruiting
Washington, District of Columbia, United States, 20307
Contact: Therese C Walden     202-782-8587     Therese.Walden@us.army.mil    
United States, Oregon
VA Medical Center, Portland Recruiting
Portland, Oregon, United States, 97201
Contact: Bonnie Becker     503-220-8262 ext 54525     Bonnie.Becker@va.gov    
Contact: Patrick Helt     (503) 220-8262 ext 58260     Patrick.Helt@va.gov    
Principal Investigator: Marjorie R. Leek, PhD            
Sponsors and Collaborators
Walter Reed Army Medical Center
Investigators
Principal Investigator: Marjorie R. Leek, PhD VA Medical Center, Portland
  More Information

Web site of the American Speech-Language Hearing Association  This link exits the ClinicalTrials.gov site
web site of Defense and Veterans Brain Injury Center  This link exits the ClinicalTrials.gov site

Responsible Party: Department of Veterans Affairs ( Leek, Marjorie - Principal Investigator )
Study ID Numbers: B5067R
Study First Received: November 5, 2007
Last Updated: September 18, 2008
ClinicalTrials.gov Identifier: NCT00554801  
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Central Auditory Processing
Traumatic Brain Injury
Hearing Loss

Study placed in the following topic categories:
Craniocerebral Trauma
Sensation Disorders
Retrocochlear Diseases
Auditory perceptual disorder
Language Development Disorders
Disorders of Environmental Origin
Brain Diseases
Ear Diseases
Signs and Symptoms
Deafness
Hearing Disorders
Mental Disorders
Brain Injuries
Hearing Loss
Dementia
Neurobehavioral Manifestations
Delirium
Otorhinolaryngologic Diseases
Wounds and Injuries
Language Disorders
Central Nervous System Diseases
Trauma, Nervous System
Cognition Disorders
Auditory Diseases, Central
Auditory Perceptual Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Neurologic Manifestations
Perceptual Disorders
Communication Disorders

Additional relevant MeSH terms:
Pathologic Processes
Disease
Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009