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Central Auditory Processing Deficits Associated With Blast Exposure

Central Auditory Processing Deficits Associated With Blast Exposure

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01567020
Enrollment
105
Registered
2012-03-30
Start date
2012-05-31
Completion date
2015-12-31
Last updated
2019-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age Factors, Blast Injuries, Brain Injuries

Keywords

Central Auditory Processing, Traumatic Brain Injury, Hearing Loss

Brief 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.

Detailed 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.

Interventions

OTHERDiagnostic

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

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory Processingsix monthsTests 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

Secondary

MeasureTime frameDescription
Ratings of Self-reported Ability to Process Auditory Information in Various Settingssix monthsHearing 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.
Functional Hearing Ability in Multitalker Environmentssix monthsThe 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.
Percent Change in P2 Component of Electrophysiological Responsesix monthsAverage 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Control
Non-blast-exposed and non-TBI, aged younger than 50 Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities.
21
Blast
Blast-exposed with or without a TBI diagnosis Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities.
41
Non-Blast-Exposed TBI
Non-blast-exposed with TBI diagnosis Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities.
18
Older
Non-blast-exposed and non-TBI, aged 50 or older Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities.
10
Total90

Baseline characteristics

CharacteristicBlastNon-Blast-Exposed TBIControlOlderTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants2 Participants2 Participants
Age, Categorical
Between 18 and 65 years
41 Participants18 Participants21 Participants8 Participants88 Participants
Age, Continuous38.4 years
STANDARD_DEVIATION 11.8
40.4 years
STANDARD_DEVIATION 10.9
31.4 years
STANDARD_DEVIATION 8.5
56.4 years
STANDARD_DEVIATION 5.5
38.82 years
STANDARD_DEVIATION 12.3
Region of Enrollment
United States
41 Participants18 Participants21 Participants10 Participants90 Participants
Sex: Female, Male
Female
2 Participants2 Participants7 Participants3 Participants14 Participants
Sex: Female, Male
Male
39 Participants16 Participants14 Participants7 Participants76 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
0 / 280 / 460 / 200 / 11
serious
Total, serious adverse events
0 / 280 / 460 / 200 / 11

Outcome results

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

Time frame: six months

Population: Note that some of the participants finished all of the primary outcome measures but withdrew without finishing all of the secondary tests. They are thus listed as having withdrawn but are still included here for completeness.

ArmMeasureGroupValue (MEAN)Dispersion
ControlNumber of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory ProcessingFrequency Pattern Test (RE)95.5 units on a scaleStandard Deviation 8.6
ControlNumber of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory ProcessingGaps in Noise (RE)4.7 units on a scaleStandard Deviation 1.1
ControlNumber of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory ProcessingMasking Level Difference13.4 units on a scaleStandard Deviation 2.9
ControlNumber of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory ProcessingStaggerred Spondaic Words (Total Errors)2.1 units on a scaleStandard Deviation 1.8
ControlNumber of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory ProcessingDichotic Digits (RE)99.1 units on a scaleStandard Deviation 1.23
BlastNumber of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory ProcessingStaggerred Spondaic Words (Total Errors)7.9 units on a scaleStandard Deviation 7.7
BlastNumber of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory ProcessingFrequency Pattern Test (RE)86.8 units on a scaleStandard Deviation 15.5
BlastNumber of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory ProcessingMasking Level Difference12.1 units on a scaleStandard Deviation 2.5
BlastNumber of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory ProcessingGaps in Noise (RE)6.4 units on a scaleStandard Deviation 2.2
BlastNumber of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory ProcessingDichotic Digits (RE)95.2 units on a scaleStandard Deviation 5.5
Non-Blast-Exposed TBINumber of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory ProcessingStaggerred Spondaic Words (Total Errors)5 units on a scaleStandard Deviation 6.04
Non-Blast-Exposed TBINumber of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory ProcessingDichotic Digits (RE)96.6 units on a scaleStandard Deviation 3.3
Non-Blast-Exposed TBINumber of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory ProcessingGaps in Noise (RE)5.6 units on a scaleStandard Deviation 1.7
Non-Blast-Exposed TBINumber of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory ProcessingFrequency Pattern Test (RE)84.3 units on a scaleStandard Deviation 21.1
Non-Blast-Exposed TBINumber of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory ProcessingMasking Level Difference12 units on a scaleStandard Deviation 2.4
OlderNumber of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory ProcessingFrequency Pattern Test (RE)90.3 units on a scaleStandard Deviation 10.8
OlderNumber of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory ProcessingGaps in Noise (RE)4.7 units on a scaleStandard Deviation 1.5
OlderNumber of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory ProcessingDichotic Digits (RE)97.5 units on a scaleStandard Deviation 3.2
OlderNumber of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory ProcessingStaggerred Spondaic Words (Total Errors)4.1 units on a scaleStandard Deviation 2.4
OlderNumber of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory ProcessingMasking Level Difference9.8 units on a scaleStandard Deviation 2.8
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.

Time frame: six months

Population: Not all participants were available for further testing.

ArmMeasureValue (MEAN)Dispersion
ControlFunctional Hearing Ability in Multitalker Environments15.2 scores on a scaleStandard Deviation 3.9
BlastFunctional Hearing Ability in Multitalker Environments19.9 scores on a scaleStandard Deviation 6.1
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.

Time frame: six months

Population: This analysis was only conducted on a subset of the sample, as not all were available for further testing.

ArmMeasureValue (MEAN)Dispersion
ControlPercent Change in P2 Component of Electrophysiological Response65.74 Percent ChangeStandard Deviation 13.8
BlastPercent Change in P2 Component of Electrophysiological Response51.87 Percent ChangeStandard Deviation 16
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.

Time frame: six months

Population: Not all participants were available for further testing.

ArmMeasureValue (MEAN)Dispersion
ControlRatings of Self-reported Ability to Process Auditory Information in Various Settings6.75 score on a scaleStandard Deviation 12.8
BlastRatings of Self-reported Ability to Process Auditory Information in Various Settings32.5 score on a scaleStandard Deviation 31.33

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026