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Sponsors and Collaborators: |
Department of Veterans Affairs Walter Reed Army Medical Center |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00554801 |
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 |
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Central Auditory Processing Disorder Traumatic Brain Injury Hearing Loss |
Procedure: Audiological testing |
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 |
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 |
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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.
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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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Experimental group:
Control group:
Exclusion Criteria:
-hearing loss greater than 50 dB HL three-frequency pure tone average bilaterally
Contact: Marjorie R Leek, PhD | (503) 220-8262 | marjorie.leek@va.gov |
Contact: Anna Diedesch | (503) 220-8262 ext 51934 | Anna.Diedesch2@va.gov |
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 |
Principal Investigator: | Marjorie R. Leek, PhD | VA Medical Center, Portland |
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 |
Central Auditory Processing Traumatic Brain Injury Hearing Loss |
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 |
Pathologic Processes Disease Nervous System Diseases |