Blast Exposed Veterans With Auditory Complaints



Status:Recruiting
Conditions:Other Indications, Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:20 - 50
Updated:4/6/2019
Start Date:August 1, 2015
End Date:December 31, 2019
Contact:Sheila R Pratt, PhD
Email:Sheila.Pratt@va.gov

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Blast-exposed Veterans With Auditory Complaints

The purpose of this study is to study blast-exposed Veterans who report hearing handicap but
show normal or near normal results on standard audiometric testing. The characteristics and
nature of their auditory and auditory-related skills will be examined, along with whether
coexisting PTSD contributes to the hearing problems of these Veterans. In a preliminary
treatment study, a sub-sample of these Veterans will be fitted with mild-gain hearing aids to
determine if they benefit from low-level amplification of high-frequency sounds.

The purpose of this study is to study blast-exposed Veterans who report hearing handicap but
show normal or near normal results on standard audiometric testing. The characteristics and
nature of their auditory and auditory-related skills will be examined with a battery of
behavioral and physiologic measures. The potential contributions of co-occurring PTSD also
will be evaluated. In a preliminary treatment study, a sub-sample of the targeted Veterans
will be fitted with mild-gain hearing aids to determine if they benefit from low-level
amplification of high-frequency sounds.

This study consists of two parts. In Part 1, four groups of Veterans, aged 20 - 50 years,
will complete a battery of auditory and auditory-related assessments to better understand the
deficit sources and patterns. The assessment measures will consist of questionnaires,
behavioral tests, and auditory physiologic measures. One group will consist of blast-exposed
Veterans with auditory problems but no PTSD. The second group will consist of blast-exposed
Veterans with auditory problems plus PTSD. The third group will consist of Veterans with PTSD
but no reported auditory problems, and the fourth groups will be a normal control group.

In Part 2 of the study, 25 participants from group 1, and 25 participants from group 2 will
be fitted with mild-gain open-fit hearing aids. Changes in hearing handicap, hearing aid
benefit, hearing aid use time, intent to continue use, and speech perception will be measured
over a 6-month period. A delayed treatment group populated from group 1 will be followed over
a 12-month period with hearing aids fitted at 6 months. The participants will be assigned
randomly from Part 1, but can decline participation.

The information obtained from this study will help us understand the auditory problems
experienced by blast-exposed Veterans and eventually contribute to the development of an
efficient and effective assessment battery and intervention approaches.

Inclusion Criteria:

- age 20 - 50 years; U.S. Veteran;

- English-speaking;

- history of blast exposure and no history of blast exposure;

- history of PTSD and no history of PTSD;

- self-perceived hearing handicap and no self-perceived hearing handicap;

- normal or near normal pure tone hearing thresholds;

- history of brain injury and no history of brain injury;

- normal vision.

Exclusion Criteria:

- hyperacusis;

- marked tinnitus;

- pure tone hearing thresholds consistent with a hearing loss;

- greater the 20/30 vision screening results (corrected or uncorrected);

- marked speech perception deficits
We found this trial at
3
sites
Portland, Oregon 97201
Phone: 503-220-8262
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Portland, OR
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Pittsburgh, Pennsylvania 15240
Principal Investigator: Sheila R Pratt, PhD
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Pittsburgh, PA
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Sioux Falls, South Dakota 57117
Phone: 605-677-5474
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Sioux Falls, SD
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