Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628505
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Auditory Plasticity Training
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Targeted Auditory Plasticity Training to Improve Central Hearing in Mild Traumatic Brain Injury mTBI
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
The study has two aims
1 Aim 1 - Speech in noise SPiN training The training group will receive the SPiN training while the active control group will play a variation of the main Listen game frequency discrimination that is not expected to improve speech recognition in noise Participants will receive a tablet and earphones The instructions will be explained and they will practice and work with the experimenter to verify they understand how to run the training at home Participants will do SPiN and Active Control training at home over 8 days with up to two 10 min sessions each day for a total of 15 training sessions
2 Aim 2 - Spacial hearing training Two groups will be tested training and control and participants will be randomly assigned to one of two groups The training group will receive Spatial Hearing training which will be compared to no-contract controls The study team will avoid withholding training from the controls by considering them a waitlist control group which will then be offered the training after completing the study as a control participantThe training group does the same spatial hearing task on two days but on every trial they are given feedback about how the location they thought the sound came from differed from the actual sound location
1 Aim 1 - Speech in noise SPiN training The training group will receive the SPiN training while the active control group will play a variation of the main Listen game frequency discrimination that is not expected to improve speech recognition in noise Participants will receive a tablet and earphones The instructions will be explained and they will practice and work with the experimenter to verify they understand how to run the training at home Participants will do SPiN and Active Control training at home over 8 days with up to two 10 min sessions each day for a total of 15 training sessions
2 Aim 2 - Spacial hearing training Two groups will be tested training and control and participants will be randomly assigned to one of two groups The training group will receive Spatial Hearing training which will be compared to no-contract controls The study team will avoid withholding training from the controls by considering them a waitlist control group which will then be offered the training after completing the study as a control participantThe training group does the same spatial hearing task on two days but on every trial they are given feedback about how the location they thought the sound came from differed from the actual sound location
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None