Central Auditory Processing Disorders Associated With Blast Exposure

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00554801
• Collaborator: Walter Reed Army Medical Center (U.S. Fed)
• Enrollment: 84
• Location: 1
• Arms: 2
• Duration (Months): 50
• Patients Per Site Per Month: 1.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Central Auditory Processing Disorder; Traumatic Brain Injury; Hearing Loss	Procedure: Audiological testing	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 84 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Central Auditory Processing Disorders Associated With Blast Exposure
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Blast 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; 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.
Active Comparator: Control 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; 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.

Outcome Measures

Primary Outcome Measures

1. Audiological Test Results [three years]

   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

1. Quality of Life Questionnaire [Three years]

   Self-report questionnaires regarding quality of life

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Marjorie R. Leek, PhD, VA Loma Linda Healthcare System, Loma Linda, CA

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

• 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. Review.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00554801
• Other Study ID Numbers: C5067-R
• First Posted: Nov 7, 2007
• Last Update Posted: Aug 10, 2018
• Last Verified: Jul 1, 2018

• Keywords provided by VA Office of Research and Development: Central Auditory Processing; Traumatic Brain Injury; Hearing Loss
• Additional relevant MeSH terms: Hearing Loss; Deafness; Auditory Perceptual Disorders; Brain Injuries; Brain Injuries, Traumatic; Language Development Disorders

Study Results

Participant Flow

Recruitment Details	Active duty military who were exposed to a blast while deployed and were patients at Walter Reed Army Medical Center; only mild or no traumatic brain injury

Arm/Group Title	Blast-exposed	Control Group
Arm/Group 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. 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.	No exposure to high-intensity blast; matched to blast-exposed group on gender, age, and hearing loss
Period Title: Overall Study
STARTED	55	29
COMPLETED	36	29
NOT COMPLETED	19	0

Baseline Characteristics

Arm/Group Title	Blast-exposed	Control Group	Total
Arm/Group 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. 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.	No exposure to high-intensity blast; matched to blast-exposed group on gender, age, and hearing loss	Total of all reporting groups
Overall Participants	36	29	65
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	32.8	32.1	32.5
Sex: Female, Male (Count of Participants)
Female	4 11.1%	3 10.3%	7 10.8%
Male	32 88.9%	26 89.7%	58 89.2%
Region of Enrollment (participants) [Number]
United States	36 100%	29 100%	65 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Blast-exposed	Control Group
Arm/Group 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. 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.	No exposure to high-intensity blast; matched to blast-exposed group on gender, age, and hearing loss
Measure Participants	36	29
Mean (Standard Deviation) [decibels Hearing Level]	10.8 (6.0)	6.6 (4.2)

2. Secondary Outcome

Title	Quality of Life Questionnaire
Description	Self-report questionnaires regarding quality of life
Time Frame	Three years

Outcome Measure Data

Analysis Population Description

It was decided early during implementation of this study that the investigators would not collect self-report data on quality of life, so there are no data to report

Arm/Group Title	Blast-exposed	Controls
Arm/Group Description	Soldiers who have been exposed to one or more blasts	Individuals who have not experienced a blast
Measure Participants	0	0

Adverse Events

Arm/Group Title	Blast-exposed		Control Group
Arm/Group 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. 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.		No exposure to high-intensity blast; matched to blast-exposed group on gender, age, and hearing loss
All Cause Mortality
	Blast-exposed		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Blast-exposed		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	Blast-exposed		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/29 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.