Comparing Hearing Aid Fitting Methods in Blast-exposed Veterans (NCT06309264) | Clinical Trial Compass
RecruitingNot Applicable
Comparing Hearing Aid Fitting Methods in Blast-exposed Veterans
United States80 participantsStarted 2024-04-01
Plain-language summary
Since 2000, at least 250,000 U.S. Service members have experienced a blast-related mild traumatic brain injury. A retrospective analysis of over 100,000 post-9/11 Veterans shows that blast injury more than doubles the risk of a diagnosed auditory problem. Many blast-exposed Veterans experience "functional hearing difficulties" (FHDs): problems in challenging listening environments despite clinically normal hearing as measured by the pure-tone audiogram. VA audiologists have begun using low-gain hearing aids to treat FHDs, but there are no concrete guidelines for this application given standard procedures rely on the pure-tone audiogram. This study proposes a data-driven approach called speech-based audiometry (SBA), which optimizes hearing aid gains from a patient's responses to speech stimuli in aided conditions. This trial will assess the behavioral (speech recognition in noise, subjective listening difficulty) and neurophysiological (functional neuroimaging during a speech recognition task) benefits of low-gain hearing aids programmed conventionally or with SBA among blast-exposed Veterans with FHDs.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. pure-tone average (PTA) at 0.5, 1, 2, 4 kHz of 35 dB HL or better in each ear;
. pure-tone thresholds no worse than 40 dB HL at any two audiometric frequencies up to 8 kHz;
. no differences in pure-tone thresholds exceeding 10 dB between the two ears at more than one audiometric frequency up to 4 kHz;
. native speaker of English; and
. a score of at least 25 on the Mini Mental State Exam.
Exclusion criteria
. a conductive hearing impairment or other otological pathology;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Modified Quick Speech-in-Noise Test (mQuickSIN) Score at 6 weeks
Timeframe: Assessed at baseline (pre-intervention; V4) and at the end of the final week of the 6-week hearing aid intervention (V11). Results will be reported through study completion, on average once per year (aligned with the RPPR).
2
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Timeframe: Assessed at the end of the final week of the 6-week hearing aid intervention (V11). Results will be reported through study completion, on average once per year (aligned with the RPPR).
. chronic disease or use of medication that might affect the auditory system or the subject's ability to perform the experimental tasks;
. an inability to perform the experimental tasks;
. any contraindications for MRI scanning (this may specifically exclude subjects who have a pacemaker, metal clips, or any other metal device in their body, or who have any other contraindication for MRI as determined by an MRI screening questionnaire); and
. experience with hearing aids prior to the study.