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Approaches to Auditory Rehabilitation for Mild Traumatic Brain Injury
NCT00930774 · View on ClinicalTrials.gov ↗
Study 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 funct
Conditions Studied
Interventions
- DEVICE FM system
- BEHAVIORAL Auditory training
Study Locations (2)
Florida
- James A. Haley Veterans Hospital, Tampa — Tampa
Oregon
- VA Medical Center, Portland — Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2010-10 |
| Est. Completion | 2012-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00930774
The ClinicalTrials.gov registry entry for NCT00930774 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 99 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is US Department of Veterans Affairs, which has 158 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Traumatic Brain Injury appearing as the primary indexed condition, and to 2 interventions — of which FM system is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00930774 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Florida, Oregon. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00930774 about?
NCT00930774 is a clinical study titled "Approaches to Auditory Rehabilitation for Mild Traumatic Brain Injury". 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 associ...
What is the current status of trial NCT00930774?
This trial is currently completed. It is a NA study. The enrollment target is 99 participants. The study started on 2010-10. Estimated completion is 2012-12.
What conditions does trial NCT00930774 study?
This clinical trial studies the following conditions: Traumatic Brain Injury. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00930774?
The interventions under investigation include: FM system (DEVICE), Auditory training (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00930774?
This trial is sponsored by US Department of Veterans Affairs, which has 158 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00930774 being conducted?
This trial has 2 study locations across Florida, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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