Blast InjuriesNCT01567020
Central Auditory Processing Deficits Associated With Blast Exposure
An observational study of Blast Injuries and Brain Injuries, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Blast Injuries, Brain Injuries, Age Factors
- What is being tested?
- Diagnostic
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Dec 2015
- How long will I take part?
- 99 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: community sample
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239
About this study
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.
Read the 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.
- Conditions
- Blast Injuries, Brain Injuries, Age Factors
- Being tested
- Diagnostic
- Keywords
- Central Auditory Processing, Traumatic Brain Injury, Hearing Loss
- Medical subject headings
- Blast Injuries, Brain Injuries, Brain Injuries, Traumatic, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiagnosticOther
All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities.
| Study group | Role | What they receive |
|---|---|---|
| Control | Non-blast-exposed and non-TBI, aged younger than 50 Receives: Other: Diagnostic | |
| Blast | Blast-exposed with or without a TBI diagnosis Receives: Other: Diagnostic | |
| Non-Blast-Exposed TBI | Non-blast-exposed with TBI diagnosis Receives: Other: Diagnostic | |
| Older | Non-blast-exposed and non-TBI, aged 50 or older Receives: Other: Diagnostic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: six months
Secondary outcomes (3)
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.
Measured: six months
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.
Measured: six months
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.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blast InjuriesStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
- Target duration
- 99 Years
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Frederick J Gallun, PhD, Principal investigator, VA Portland Health Care System, Portland, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567020
- Sponsor's protocol ID
- C7755-I
- Status last verified
- Mar 2019
- First submitted
- 2 Mar 2012
- Last updated
- 14 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data sharing will be through an established data repository overseen by the VA Portland HCS IRB.
Publications
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. doi: 10.1682/jrrd.2008.09.0118.
PubMed 20104403
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Auditory Processing Deficits Associated With Blast Exposure
- ClinicalTrials.gov ID
- NCT01567020
- Acronym / sponsor ID
- C7755-I
- Conditions
- Blast Injuries, Brain Injuries, Age Factors
- Keywords
- Central Auditory Processing, Traumatic Brain Injury, Hearing Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- May 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Mar 2012 (estimated)
- Results
- Posted 8 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 99 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: DiagnosticNon-blast-exposed and non-TBI, aged younger than 50 |
| Blast | – | Other: DiagnosticBlast-exposed with or without a TBI diagnosis |
| Non-Blast-Exposed TBI | – | Other: DiagnosticNon-blast-exposed with TBI diagnosis |
| Older | – | Other: DiagnosticNon-blast-exposed and non-TBI, aged 50 or older |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- community sample
Key inclusion criteria (14 listed)
- Aged 18-90
- Pure-tone sensitivity of 40 dB HL or better at all audiometric frequencies below 8 kHz
- English as first language.
- Group 1: Blast exposed Veterans
- Report having been exposed to high-intensity blast during the ten years prior to enrollment
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiagnosticAll participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities. | Other | Blast, Control, Non-Blast-Exposed TBI, Older |
Primary outcome
Number of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory Processing
Time frame: six months
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
3 secondary outcomes
Ratings of Self-reported Ability to Process Auditory Information in Various Settings
Time frame: six months
Functional Hearing Ability in Multitalker Environments
Time frame: six months
Percent Change in P2 Component of Electrophysiological Response
Time frame: six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20104403Fausti 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. doi: 10.1682/jrrd.2008.09.0118.
- Individual participant dataSharing planned: Yes. Data sharing will be through an established data repository overseen by the VA Portland HCS IRB.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick J Gallun, PhD principal investigator
VA Portland Health Care System, Portland, OR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blast Injuries and Brain Injuries, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory Processing (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01567020, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2019.