Central Auditory Processing Disorders Associated With Blast Exposure

NCT00554801 | Completed Results

• 1 other identifier: C5067-R
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Auditory Processing Disorder; Traumatic Brain Injury; Hearing Loss

Keywords

Central Auditory Processing; Traumatic Brain Injury; Hearing Loss

Outcome Measures

Primary Outcomes (1)

• 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.

  three years

Secondary Outcomes (1)

• Quality of Life Questionnaire

  Three years

Study Arms (2)

Blast

EXPERIMENTAL

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.

Procedure: Audiological testing

Control

ACTIVE COMPARATOR

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

Procedure: Audiological testing

Interventions

Audiological testing PROCEDURE

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.

Blast; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Walter Reed Army Medical Center: collaborator

Study Sites (1)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

Related Publications (2)

• 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.

  PMID: 23341279 BACKGROUND

• 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.

  PMID: 23341276 RESULT

Related Links

• Web site of the American Speech-Language Hearing Association
• web site of Defense and Veterans Brain Injury Center

MeSH Terms

Conditions

Language Development Disorders; Brain Injuries, Traumatic; Hearing Loss

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders

Limitations and Caveats

A quality-of-life self-report questionnaire was not implemented for this study, and so no data on this outcome were collected

Results Point of Contact

• Title: Marjorie R. Leek
• Organization: Portland VA Medical Center

Marjorie.Leek@va.gov

503-220-8262

Study Officials

• Marjorie R. Leek, PhD

  VA Loma Linda Healthcare System, Loma Linda, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2007
• First Posted: November 7, 2007
• Study Start: October 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2011
• Last Updated: August 10, 2018
• Results First Posted: November 13, 2014

Record last verified: 2018-07

Locations

US (1)