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NCT00930774 · ClinicalTrials.gov registry record · NA
Approaches to Auditory Rehabilitation for Mild Traumatic Brain Injury
A NA study of Traumatic Brain Injury, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- NA
- Development phase
- 99
- Enrollment target
- 2
- Study locations
NCT00930774: Completed NA study of Traumatic Brain Injury, sponsored by US Department of Veterans Affairs.
NCT00930774 is a NA study of Traumatic Brain Injury that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 99 participants, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (64% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00930774, a NA study of Traumatic Brain Injury, has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- NA
- Development phase
- 99 participants
- Enrollment target
- 2
- Study locations
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
Primary Outcome
Assesses the impact a rehabilitative intervention has on perceived Competence (perceived functional capability, independence and performance). Responses are reported on a 7-point scale that ranges from -3 (maximum negative impact) to +3 (maximum positive impact). The mid-point, zero, indicates no impact or no perceived change
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 |
What the finished NCT00930774 record still lists
NCT00930774 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (64% lower).
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.
NCT00930774 reports a single indexed study location in Florida, Oregon.
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.
What interventions are being tested in trial NCT00930774?
The interventions under investigation include: FM system (DEVICE), Auditory training (BEHAVIORAL).
Who is sponsoring clinical trial NCT00930774?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT00930774's enrollment target sits among peer trials
99 74th of 171 higher than 98 of 171 other Traumatic Brain Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Traumatic Brain Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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