Blast Exposed Veterans With Auditory Complaints

VA Office of Research and Development

Status: Completed

Conditions: Hearing Aid Fitting; Hearing Impairment

Treatments: Device: mild-gain hearing aids with high-frequency emphasis over 6-months

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02122458

C1164-R

Details and patient eligibility

About

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.

Full description

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 (clinical trial portion), a smaller group of participants from the first and second groups will be fitted with mild-gain open-fit hearing aids to determine if they benefit from mild high-frequency amplification. Changes in hearing handicap and speech perception will be compared from baseline to 6-months post-fitting. Perceived hearing aid benefit, hearing aid use time, and intent to continue use will be measured at the end of a 6-month treatment period. A delayed treatment group will be formed from group 1 and will be followed over a 12-month period with hearing aids fitted at 6 months. The participants will be assigned randomly from Part 1 of the study.

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.

Enrollment: 363 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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363 participants in 7 patient groups

Immediate Hearing Aid Treatment: Blast-exposed Only

Active Comparator group

Description:

This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.

Treatment:

Device: mild-gain hearing aids with high-frequency emphasis over 6-months

Immediate Hearing Aid Treatment: Blast-exposed with PTSD

Active Comparator group

Description:

This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.

Treatment:

Device: mild-gain hearing aids with high-frequency emphasis over 6-months

Delayed Hearing Aid Treatment: Blast-exposed Only

Active Comparator group

Description:

This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with hearing aids after a 6-month delay. Their performance was monitored 6-months pre-fitting and for the 6 months after the fitting.

Treatment:

Device: mild-gain hearing aids with high-frequency emphasis over 6-months

Non-treatment Diagnostic Testing: Normal

No Intervention group

Description:

This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group included neurotypical Veterans with normal hearing and were negative for blast-exposure and PTSD.

Non-Treatment Diagnostic Testing: Blast-exposed Only

No Intervention group

Description:

This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. They were negative for significant PTSD.

Non-treatment Diagnostic Testing: Blast-exposed with PTSD

No Intervention group

Description:

This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD.

Non-treatment Diagnostic Testing: PTSD Only

No Intervention group

Description:

This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group was negative for blast-exposure and hearing loss but positive for significant PTSD.