N/A
N=99
Approaches to Auditory Rehabilitation for Mild Traumatic Brain Injury
Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT00930774 ↗Enrolled (actual)
99
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Competence Score From the Psychosocial Impact of Assistive Devices Scale (PIADS) — 0.56; .37; .62; .41 units on a scale — p=0.527
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FM system (Device); Auditory training (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Competence Score From the Psychosocial Impact of Assistive Devices Scale (PIADS) |
0.56; .37; .62; .41 | 0.527 |
| PRIMARY Stroop Color and Word Test |
1.2; 0.4; 1.1; 1.6 | 0.835 |
| SECONDARY Hearing in Noise Test |
-8.1; -8.1; -8.2; -7.9 | 0.983 |
| SECONDARY Staggered Spondaic Word Test |
5.1; 2.6; 5.2; 5.3 | 0.554 |
| SECONDARY Digit Span Score Measure of Auditory Working Memory |
16; 17.5; 16.1; 16.4 | 0.757 |
| SECONDARY Time Compressed Speech Test (TCST) |
92.8; 93.8; 89.5; 90.9 | 0.302 |
| SECONDARY Cognitive Self Report Questionnaire (CSRQ). |
11.5; 10.3; 17.1; 0 | 0.001 sig |
| SECONDARY Speech, Spatial and Qualities of Hearing Scale-comparative (SSQ-C) |
1.0; 0.4; 1.0; 0.3 | 0.013 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00930774). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.