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| ID | Type | Description | Link |
|---|---|---|---|
| TP230338P1 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The investigators are working on a project to help people who have had mild brain injuries hear better. Sometimes, these injuries can make it hard for people to hear clearly, especially in noisy places or when trying to tell where sounds are coming from.
The project is testing special training exercises that have helped healthy people improve their hearing in these situations. The goal is to see if these exercises can also help people with mild traumatic brain injuries (mTBI).
If these exercises work, they could help doctors give better treatment to people with hearing problems after a brain injury. This would be especially helpful for soldiers who need to stay ready for duty. It could also make life better for veterans who struggle with hearing issues and help lower the cost of healthcare.
The study has two aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Speech in Noise Training (SPiN) | Active Comparator | Young to middle-age mTBI patients (age 18-55 yrs.) with various degrees of central hearing impairment will be randomly assigned to this training group |
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| SPiN Control Group Treatment as Usual (TAU) | No Intervention | Young to middle-age mTBI patients (age 18-55 yrs.) with various degrees of central hearing impairment will be randomly assigned to a treatment as usual group | |
| Spatial Hearing Training | Active Comparator | Young to middle-age mTBI patients (age 18-55 yrs.) with various degrees of central hearing impairment will be randomly assigned to this training group |
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| Spatial Hearing Training Control Group Treatment as Usual (TAU) | Other | Young to middle-age mTBI patients (age 18-55 yrs.) with various degrees of central hearing impairment will be randomly assigned to a treatment as usual group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Speech in Noise Training | Other | The active controls will receive frequency discrimination training that uses the same visual landscape and basic task of controlling the wisp based on judgments about acoustic cues. The task requires participants to avoid obstacles by swiping upward or downward on the touchscreen to indicate whether a test frequency associated with the obstacle was higher or lower, respectively, than a target sound presented slightly before the test sound. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Composite Hearing in Noise Score | The composite score will be the averaging (equal weighting) of z-scores from two tests: Spatial Release from Masking and Digits in Noise. Each test uses measures of decibels (dB), where smaller dB values indicate better performance. | Baseline to 1 month + 10 days |
| Change in Frequency Following Response (FFR): Cross Correlation of FFR and Stimulus | The time point of maximum correlation between the FFR and stimulus waveforms will be calculated. Larger correlation values indicate a more precise neural representation of the stimulus. A Fisher r-to-z transformation will be used to normalize the distribution of correlation values. | Baseline to 1 month + 10days |
| Change in Frequency Following Response : Amplitude of stimulus fundamental frequency | The amplitude of the fundamental frequency will be defined using fast Fourier-transforms, and measured in microvolts. Larger values indicate greater amplitudes. | Time Frame: Baseline to 1 month + 10days |
| Change in Spatial Hearing: Sound localization Precision | Sound localization precision will be measured as the absolute difference (in degrees) between the locations of the pointer and the sound target location in the horizontal plane. Smaller values indicate better spatial hearing precision. | Baseline to 1 month + 4 days |
| Change in Spatial Hearing: percent of front/back confusions. | Localization errors > 45° that cross the interaural axis will be categorized as front/back confusions. The percentage of Front/back confusions among all trials will be measured, and larger percentages indicate worse spatial hearing. | Baseline to 1 month + 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rocio Norman, PhD | Contact | (210) 450-8352 | normanr@uthscsa.edu | |
| Alicia Swan, PhD | Contact | (210) 671-5300 | Alicia.swan@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Rocio Norman, PhD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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A randomized controlled trial which will randomize subjects into one of two aims. Each aim will have a 1:1 randomization of participants into either the investigational or the control group
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| Spatial Hearing Training Group | Other | Stimulus presentation and response measurement (Aim 2): Acoustic stimuli will be presented with a 360° speaker array that are fixed in place behind an opaque, nearly sound transparent, acoustic fabric curtain to avoid visual influences. Manual responses will be collected using a keyboard. Custom Matlab scripts control all relevant variables with millisecond precision. A webcam monitors the participant (not recorded) for the sole purpose of making sure the participant is always facing straight ahead. Sound localization task and training: Participants will judge the location of a target white noise sound (1000 ms, 70 dB SLP, 10-10,000 Hz) by moving an auditory pointer that appears 2 seconds after the offset of the target sound. The training group are given feedback about how their perceived location related to the actual sound location. |
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| Spatial Hearing Control Group | Other | Stimulus presentation and response measurement (Aim 2): Acoustic stimuli will be presented with a 360° speaker array that are fixed in place behind an opaque, nearly sound transparent, acoustic fabric curtain to avoid visual influences. Manual responses will be collected using a keyboard. Custom Matlab scripts control all relevant variables with millisecond precision. A webcam monitors the participant (not recorded) for the sole purpose of making sure the participant is always facing straight ahead. Sound localization task and training: Participants will judge the location of a target white noise sound (1000 ms, 70 dB SLP, 10-10,000 Hz) by moving an auditory pointer that appears 2 seconds after the offset of the target sound. The training group are NOT given feedback about how their perceived location related to the actual sound location. |
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| Change in P300 amplitude. | Amplitude of the P300 event-related potential in response to target sounds will be measured (in microvolts). Larger amplitudes indicate better spatial attention processing. | Baseline to 1 month + 4 days |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |