Recruiting

Hearing Training

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT06628505

Conditions

Mild Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Speech in Noise Training

Spatial Hearing Training Group

Spatial Hearing Control Group

Study Details

Brief summary:

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.

Conditions

Mild Traumatic Brain Injury

Study ID

NCT06628505

Start date

Sep 15, 2024

Status verified date

Nov, 2025

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Mar 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18-55 years
  • English is the primary language
  • History of mTBI by self report

Exclusion Criteria:

  • Pure tone threshold (mean of 0.5-4.0 kHz) > 40dB HL
  • Major neurological or psychiatric conditions besides mTBI

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Speech in Noise Training (SPiN)

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

no intervention: SPiN Control Group Treatment as Usual (TAU)

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

active comparator: Spatial Hearing Training

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

other: Spatial Hearing Training Control Group Treatment as Usual (TAU)

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

Interventions

Speech in Noise Training

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.

Spatial Hearing Training Group

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.

Spatial Hearing Control Group

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.

Primary outcome measure

  • Change in Composite Hearing in Noise Score [ Time Frame: Baseline to 1 month + 10 days ]
  • Change in Frequency Following Response (FFR): Cross Correlation of FFR and Stimulus [ Time Frame: Baseline to 1 month + 10days ]
  • Change in Frequency Following Response : Amplitude of stimulus fundamental frequency [ Time Frame: Time Frame: Baseline to 1 month + 10days ]
  • Change in Spatial Hearing: Sound localization Precision [ Time Frame: Baseline to 1 month + 4 days ]
  • Change in Spatial Hearing: percent of front/back confusions. [ Time Frame: Baseline to 1 month + 4 days ]
  • Change in P300 amplitude. [ Time Frame: Baseline to 1 month + 4 days ]

Central Contacts and Locations

Central contacts

Rocio Norman, PhD

(210) 450-8352normanr@uthscsa.edu

Alicia Swan, PhD

(210) 671-5300Alicia.swan@va.gov

Locations

The University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Rocio Norman, PhD

210-450-8352normanr@uthscsa.edu

Alicia Swan, PhD

210-671-5300 x14028Alicia.swan@va.gov

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

Nov 21, 2025

Last verified

Nov, 2025

Keywords

  • Auditory plasticity
  • Hearing training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2025-11-21.