Blast Exposed Veterans With Auditory Complaints
Condition: Hearing Impairment; Hearing Aid Fitting
MeSH terms: Hearing Loss; Deafness
Study type: Interventional

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.
    

Intervention name(s): mild-gain hearing aids with high-frequency emphasis over 6-months
Intervention type(s): Device
Intervention description(s): open-fit hearing aids with mild amplification in the high frequencies.
Other intervention name(s): hearing aids
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The primary study was diagnostic, with a goal of better understanding and determining the best diagnostic assessment battery for capturing the hearing and auditory problems reported by blast-exposed Veterans. The secondary purpose was to implement a preliminary treatment study to determine if blast-exposed Veterans with hearing complaints, but normal audiometric data benefited from low-gain hearing aids. This secondary treatment study is the clinical trial portion of this study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hearing impairment; post-traumatic stress disorder; traumatic brain injury; auditory processing disorder