N/A
N=105
Central Auditory Processing Deficits Associated With Blast Exposure
Blast Injuries · Brain Injuries · Age Factors
Bottom Line
View on ClinicalTrials.gov: NCT01567020 ↗Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Number of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory Processing — 99.1; 95.2; 96.6; 97.5 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Diagnostic (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory Processing |
99.1; 95.2; 96.6; 97.5; 4.7; 6.4 | — |
| SECONDARY Ratings of Self-reported Ability to Process Auditory Information in Various Settings |
6.75; 32.5 | — |
| SECONDARY Functional Hearing Ability in Multitalker Environments |
15.2; 19.9 | — |
| SECONDARY Percent Change in P2 Component of Electrophysiological Response |
65.74; 51.87 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01567020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.