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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

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 groups in NCT01567020
Study groupRoleWhat they receive
ControlNon-blast-exposed and non-TBI, aged younger than 50
Receives: Other: Diagnostic
BlastBlast-exposed with or without a TBI diagnosis
Receives: Other: Diagnostic
Non-Blast-Exposed TBINon-blast-exposed with TBI diagnosis
Receives: Other: Diagnostic
OlderNon-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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted30 Mar 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

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
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
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

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.

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