Trials / Completed
CompletedNCT02122458
Blast Exposed Veterans With Auditory Complaints
Blast-exposed Veterans With Auditory Complaints
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 363 (actual)
- Sponsor
- VA Office of Research and Development · Federal
- Sex
- All
- Age
- 20 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | mild-gain hearing aids with high-frequency emphasis over 6-months | open-fit hearing aids with mild amplification in the high frequencies. |
Timeline
- Start date
- 2015-08-01
- Primary completion
- 2020-11-30
- Completion
- 2020-12-31
- First posted
- 2014-04-24
- Last updated
- 2023-06-22
- Results posted
- 2023-06-22
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02122458. Inclusion in this directory is not an endorsement.