Trial Outcomes & Findings for Central Auditory Processing Deficits Associated With Blast Exposure (NCT NCT01567020)
NCT ID: NCT01567020
Last Updated: 2019-06-14
Results Overview
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
COMPLETED
105 participants
six months
2019-06-14
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
28
|
46
|
20
|
11
|
|
Overall Study
COMPLETED
|
21
|
41
|
18
|
10
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Central Auditory Processing Deficits Associated With Blast Exposure
Baseline characteristics by cohort
| Measure |
Control
n=21 Participants
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.
|
Blast
n=41 Participants
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.
|
Non-Blast-Exposed TBI
n=18 Participants
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.
|
Older
n=10 Participants
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.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
88 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Age, Continuous
|
31.4 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
38.4 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
40.4 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
56.4 years
STANDARD_DEVIATION 5.5 • n=4 Participants
|
38.82 years
STANDARD_DEVIATION 12.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
90 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: six monthsPopulation: 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.
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
Outcome measures
| Measure |
Control
n=22 Participants
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.
|
Blast
n=42 Participants
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.
|
Non-Blast-Exposed TBI
n=14 Participants
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.
|
Older
n=11 Participants
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.
|
|---|---|---|---|---|
|
Number of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory Processing
Staggerred Spondaic Words (Total Errors)
|
2.1 units on a scale
Standard Deviation 1.8
|
7.9 units on a scale
Standard Deviation 7.7
|
5 units on a scale
Standard Deviation 6.04
|
4.1 units on a scale
Standard Deviation 2.4
|
|
Number of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory Processing
Dichotic Digits (RE)
|
99.1 units on a scale
Standard Deviation 1.23
|
95.2 units on a scale
Standard Deviation 5.5
|
96.6 units on a scale
Standard Deviation 3.3
|
97.5 units on a scale
Standard Deviation 3.2
|
|
Number of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory Processing
Gaps in Noise (RE)
|
4.7 units on a scale
Standard Deviation 1.1
|
6.4 units on a scale
Standard Deviation 2.2
|
5.6 units on a scale
Standard Deviation 1.7
|
4.7 units on a scale
Standard Deviation 1.5
|
|
Number of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory Processing
Frequency Pattern Test (RE)
|
95.5 units on a scale
Standard Deviation 8.6
|
86.8 units on a scale
Standard Deviation 15.5
|
84.3 units on a scale
Standard Deviation 21.1
|
90.3 units on a scale
Standard Deviation 10.8
|
|
Number of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory Processing
Masking Level Difference
|
13.4 units on a scale
Standard Deviation 2.9
|
12.1 units on a scale
Standard Deviation 2.5
|
12 units on a scale
Standard Deviation 2.4
|
9.8 units on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: six monthsPopulation: Not all participants were available for further testing.
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.
Outcome measures
| Measure |
Control
n=13 Participants
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.
|
Blast
n=16 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Ratings of Self-reported Ability to Process Auditory Information in Various Settings
|
6.75 score on a scale
Standard Deviation 12.8
|
32.5 score on a scale
Standard Deviation 31.33
|
—
|
—
|
SECONDARY outcome
Timeframe: six monthsPopulation: Not all participants were available for further testing.
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.
Outcome measures
| Measure |
Control
n=13 Participants
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.
|
Blast
n=16 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Functional Hearing Ability in Multitalker Environments
|
15.2 scores on a scale
Standard Deviation 3.9
|
19.9 scores on a scale
Standard Deviation 6.1
|
—
|
—
|
SECONDARY outcome
Timeframe: six monthsPopulation: This analysis was only conducted on a subset of the sample, as not all were available for further testing.
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.
Outcome measures
| Measure |
Control
n=16 Participants
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.
|
Blast
n=13 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Percent Change in P2 Component of Electrophysiological Response
|
65.74 Percent Change
Standard Deviation 13.8
|
51.87 Percent Change
Standard Deviation 16
|
—
|
—
|
Adverse Events
Control
Blast
Non-Blast-Exposed TBI
Older
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place