Central Auditory Processing Deficits Associated With Blast Exposure

NCT01567020 | Completed Results

• 1 other identifier: C7755-I
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Blast Injuries; Brain Injuries; Age Factors

Keywords

Central Auditory Processing; Traumatic Brain Injury; Hearing Loss

Outcome Measures

Primary Outcomes (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

  six months

Secondary Outcomes (3)

• Ratings of Self-reported Ability to Process Auditory Information in Various Settings

  six months

• Functional Hearing Ability in Multitalker Environments

  six months

• Percent Change in P2 Component of Electrophysiological Response

  six months

Study Arms (4)

Control

Non-blast-exposed and non-TBI, aged younger than 50

Other: Diagnostic

Blast

Blast-exposed with or without a TBI diagnosis

Other: Diagnostic

Non-Blast-Exposed TBI

Non-blast-exposed with TBI diagnosis

Other: Diagnostic

Older

Non-blast-exposed and non-TBI, aged 50 or older

Other: Diagnostic

Interventions

Diagnostic OTHER

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

Blast; Control; Non-Blast-Exposed TBI; Older

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

community sample

You may qualify if:

• 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
• 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
• years.
• Older group will be aged 60 and older

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

Related 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. doi: 10.1682/jrrd.2008.09.0118.

  PMID: 20104403 BACKGROUND

Biospecimen

Retention: NONE RETAINED

None collected.

MeSH Terms

Conditions

Blast Injuries; Brain Injuries; Brain Injuries, Traumatic; Hearing Loss

Condition Hierarchy (Ancestors)

Barotrauma; Wounds and Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Frederick Gallun
• Organization: VA Portland Health Care System

Frederick.Gallun@va.gov

5032208262

Study Officials

• Frederick J Gallun, PhD

  VA Portland Health Care System, Portland, OR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 99 Years
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2012
• First Posted: March 30, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 14, 2019
• Results First Posted: February 8, 2017

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Available starting Jan 2016, and continuing to be available as long as a repository director is available to oversee the data.
• Access Criteria: IRB approved protocol allowing data to be transferred from repository to recipient study.

Locations

US (1)