Central Auditory Processing Deficits Associated With Blast Exposure

Brain Injuries Clinical Trial

Official title:

Central Auditory Processing Deficits Associated With Blast Exposure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01567020
• Other study ID #: C7755-I
• Status: Completed
• Start date: May 2012
• Est. completion date: December 2015

Study information

• Verified date: March 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The current conflicts in Afghanistan and Iraq have resulted in unprecedented rates of exposure to high-intensity blasts and resulting brain injury. This research team has established that recently blast-exposed Soldiers show differences from controls on tests of central auditory function. This project will 1) develop a more accurate estimate of the prevalence of central auditory dysfunction among Veterans exposed to blasts over the past ten years, 2) identify the functional outcomes associated with abnormal performance on tests of central processing, and 3) improve understanding of the ways in which blast-exposure resembles and differs from both the normal aging process and non-blast-related TBI in terms of performance on tests of central auditory processing.

Description:

The current conflicts in Afghanistan (Operation Enduring Freedom; OEF) and Iraq (Operation Iraqi Freedom; OIF) have resulted in unprecedented rates of exposure to high-intensity blasts and resulting brain injury. Dennis (2009) reports that during 2005-2007, 68% of U.S. military personnel injured in the OEF/OIF conflicts had blast-related injuries and 28%-31% of those evacuated to Walter Reed Army Medical Center (WRAMC), Washington, DC had brain injuries. While the common focus of auditory evaluation is on damage to the peripheral auditory system, the prevalence of brain injury among those exposed to high-intensity blasts suggests that damage to the central auditory system is an equally important concern for the blast-exposed Veteran. Discussions with clinical audiologists and OEF/OIF Veterans Service Office personnel suggest that a common complaint voiced by blast-exposed Veterans is an inability to understand speech in noisy environments, even when peripheral hearing is within normal or near-normal limits (see attached letters of support). Such complaints are consistent with damage to neural networks responsible for higher-order auditory processing. This proposal is the second phase of a research project focused on examining the degree to which central auditory processing (CAP) dysfunction is a result of blast exposure. Over the initial period of funding, data collection at WRAMC and the VA RR&D National Center for Rehabilitative Auditory Research (NCRAR) established that CAP dysfunction is present in Warfighters exposed to high-intensity blasts while serving in combat. Recently blast-exposed patients with and without diagnoses of mild traumatic brain injury (mTBI) tested at WRAMC showed differences from controls tested at NCRAR on one or more behavioral and neurophysiological tests used to evaluate central auditory function. This project will 1) develop a more accurate estimate of the prevalence of central auditory dysfunction among Veterans exposed to blasts over the past ten years, 2) identify the functional outcomes associated with abnormal performance on tests of central processing, and 3) improve understanding of the ways in which blast-exposure resembles and differs from both the normal aging process and non-blast-related TBI in terms of performance on tests of central auditory processing.

Key Question 1: To what extent is CAP dysfunction observable among OEF/OIF Veterans who have been exposed to high intensity blasts? Based on preliminary data, the investigators hypothesize that the rate of abnormal performance on behavioral and neurophysiological tests of CAP dysfunction will be higher in a group of Veterans exposed to blasts than it will be in a control group of similar ages and hearing thresholds who have not been exposed to blasts.

Key Question 2: How well can behavioral and neurophysiological tests of CAP predict functional auditory deficits measured behaviorally and through self report? It is hypothesized that tests of CAP ability will predict performance in a testing situation involving multiple talkers delivering competing messages. CAP tests will also correlate with responses blast-exposed Veterans make on the Speech and Spatial Qualities of Hearing (SSQ) questionnaire, designed to examine functional hearing ability in various acoustically complex environments.

Key Question 3: To what extent do blast-exposed Veterans resemble older listeners and participants with mild TBI who have not been exposed to blasts in their performance on CAP tests and functional tests of hearing? It is hypothesized that comparisons of the blast-exposed group with an older group with matched pure-tone sensitivity and an age- and hearing-matched group with non-blast-related TBI will be consistent with premature aging in the blast-exposed group but demonstrate substantive differences with the non-blast group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Aged 18-90

• Pure-tone sensitivity of 40 dB HL or better at all audiometric frequencies below 8 kHz

• English as first language.

Group membership inclusion criteria:

Group 1: Blast exposed Veterans

• Report having been exposed to high-intensity blast during the ten years prior to enrollment

• Cognitive and physical ability to take part in these auditory evaluations

Group 2. Non-blast TBI group

• Diagnosed with mild-to-moderate TBI

Group 3. Age matched control group -18-59 years.

Group 4. Older control group

• 60-90 years.

• Older group will be aged 60 and older

Audiometric status of these groups will be required to meet the same exclusion criteria as that of the other two groups described above

Exclusion Criteria:

• Evidence of conductive or retrocochlear dysfunction

• Hearing loss exceeding pure-tone averages for frequencies of .5, 1, 2, and 4 kHz of 35 dB HL

--Hearing loss of greater than 40 dB HL at any one of these frequencies in either ear

• Asymmetrical hearing thresholds exceeding 10 dB at any audiometric frequency below 4 kHz

• Abnormal cognitive function as indicated by scores of 23 or below on the Mini Mental State Exam

• Indications of clinical depression as evidenced by a score of 17 or greater on the Beck Depression Inventory

Related Conditions & MeSH terms

• Age Factors
• Blast Injuries
• Brain Injuries
• Wounds and Injuries

Intervention

Other:
• Diagnostic
All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities.

Locations

Country	Name	City	State
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Fausti SA, Wilmington DJ, Gallun FJ, Myers PJ, Henry JA. Auditory and vestibular dysfunction associated with blast-related traumatic brain injury. J Rehabil Res Dev. 2009;46(6):797-810. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory Processing	Tests to be administered: Dichotic Digits Test: Percentage of digits reported correctly from 0 (worst performance) to 100 (best performance) Gaps in Noise Test: Approximate threshold in milliseconds from 2 (best) to 20 (worst) Staggered Spondaic Words Test: Total number of errors from 0 (best) to 40 (worst) Masking Level Differences Test: Difference in threshold between diotic and dichotic stimuli in decibels from 0 (worst) to 24 (best) Frequency Pattern Test: Percentage of sequences reported correctly from 0 (worst performance) to 100 (best performance) Adaptive Tests of Temporal Resolution: Not reported due to software error in stimulus presentation	six months
Secondary	Ratings of Self-reported Ability to Process Auditory Information in Various Settings	Hearing Health Inventory for Adults is a 25 item questionnaire that asks participants to rank how often auditory issues create problems in daily life. Scores range from 0 to 100, with higher scores indicating greater perceived levels of handicap.	six months
Secondary	Functional Hearing Ability in Multitalker Environments	The Functional Hearing Questionnaire (FHQ), developed for veterans with brain injuries was used to evaluate self perceived hearing difficulties. The FHQ is a nine item questionnaire that asks participants to rate their level of difficulty hearing in different circumstances on a four point scale. Scores range from 9 to 36, with higher scores indicating a greater level of difficulty.	six months
Secondary	Percent Change in P2 Component of Electrophysiological Response	Average change in amplitude of the P2 component of the electrophysiological response to paired clicks. Habituation to the clicks is anticipated, resulting in a large percentage change in amplitude to the second click.	six months