Approaches to Auditory Rehabilitation for Mild Traumatic Brain Injury

Completed · Not applicable

Conditions studied: Traumatic Brain Injury

In brief

Many soldiers returning from their recent service in Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) were exposed to blasts during combat. About 60% of blast-injured soldiers are diagnosed with traumatic brain injury (TBI), with approximately 18% having a mild TBI (mTBI). mTBI is associated with many symptoms, including memory problems, headaches, difficulty concentrating, increased anxiety, and, especially relevant here, reports of difficulty understanding speech in noisy environments and/or when people speak rapidly. While problems understanding rapid speech or speech in noise are associated with hearing loss, many of the OIF/OEF veterans with these complaints have clinically normal hearing. Although there is no physical damage to their ears, these veterans' hearing problems have a negative impact on their quality-of-life and functioning. Thus it is incumbent upon the VA to examine intervention approaches for veterans with normal/near-normal auditory sensitivity and significant complaints of difficulty hearing. Currently, there is no standard-of-care for these veterans other than providing information about hearing, hearing conservation, and the use of communication strategies. Two forms of rehabilitation likely to be more effective than such an informational-counseling approach are: (1) the use of personal miniaturized Frequency modulation (FM) systems, and (2) the provision of auditory training with Posit Science Brain Fitness Program (BFP). Personal FM systems increase the loudness of the speech signal relative to that of the unwanted noise, while the BFP training improves the ability to listen by taking advantage of the brain's ability to change (i.e., neural plasticity). In this study veterans will randomly be selected to receive one of four treatments: (1) FM use alone, (2) BFP training alone, (3) FM+BFP training combined, and (4) informational-counseling. The effectiveness of the interventions will be compared using self-report of hearing functioning on standard questionnaires. Results will contribute to the development of evidence-based intervention approaches for blast-exposed veterans with reported functional hearing difficulties and normal/near-normal auditory sensitivity.

Key facts

Study ID: NCT00930774
Run by: US Department of Veterans Affairs
People needed: 99
Starts: 2010-10-01
Expected to finish: 2012-12-01
Last updated by the study team: 2014-06-11

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participants will be OIF/OEF veterans with no exclusions based on age, ethnicity, or gender. To be included in the study participants will:
Report difficulty understanding speech in difficult listening environments disproportionate to loss in hearing sensitivity, as defined by self-referral to the study
Have hearing thresholds <= 65 decibels hearing loss (dB HL) at 0.5, 1.0, 2.0, 3.0 \& 4.0 kilohertz (kHz)
Cognitive abilities sufficient to participate in the study, as determined by an age and education-level appropriate score on the Mini Mental State Exam (MMSE; Folstein, Robins, \& Helzer, 1983; Crum et al., 1993),
English as a first language,
Openness to using a personal FM system for a four-week period and/or to conducting auditory training over an eight-week period, as determined through interview.

You may not qualify if…

Asymmetric pure tone thresholds (left-right difference > 15 dB HL at frequencies of 500 through 4000 Hz),
Presence of neurological, psychiatric or physical disorders, or co-morbid diseases that would prevent completion of the study as determined by chart review,
Best corrected vision worse than 20/63 as measured with the Smith-Kettlewell Institute Low Luminance (SKILL) Card

Where it is running

James A. Haley Veterans Hospital, Tampa — Tampa, Florida, United States
VA Medical Center, Portland — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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