Comparing hearing aid fitting methods for veterans exposed to blasts
Benefits of Speech-based Audiometry and Low-gain Hearing Aids for Blast-exposed Veterans
This study is testing two different ways to fit hearing aids for veterans with blast-related injuries to see which method helps them hear better and feel more comfortable.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 3 sites (Loma Linda, California and 2 other locations) |
| Trial ID | NCT06309264 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of two different hearing aid fitting methods for veterans who have experienced blast-related injuries. It focuses on veterans with normal or near-normal hearing who report functional hearing difficulties. Participants will be randomly assigned to receive either conventional hearing aid programming or a novel speech-based audiometry approach. The study will track their speech recognition abilities and subjective listening difficulties over a six-week intervention period. The goal is to determine which method provides better outcomes for this specific population.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans aged 18 to 60 who have experienced high-intensity blast exposure and report functional hearing difficulties despite having normal hearing.
Not a fit: Patients with conductive hearing impairments or other significant otological pathologies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved hearing aid fitting methods that enhance the quality of life for veterans with hearing difficulties.
How similar studies have performed: While there is limited research specifically on speech-based audiometry for this population, similar approaches in hearing aid fitting have shown promise in improving outcomes for patients with hearing difficulties.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Human subjects will be male or female Veterans selected without regard to race or ethnic background. All subjects will be 18 years of age or older and no more than 60 years old. On the QCuBE, all subjects must report at least one exposure to high-intensity blast (e.g., RPG, IED, mortar) close enough to feel the heat or pressure of the blast wave. All subjects must also score 20 or higher on the Hearing Handicap Inventory for Adults (HHIA). The remaining inclusion criteria for all subjects are: 1. pure-tone average (PTA) at 0.5, 1, 2, 4 kHz of 35 dB HL or better in each ear; 2. pure-tone thresholds no worse than 40 dB HL at any two audiometric frequencies up to 8 kHz; 3. no differences in pure-tone thresholds exceeding 10 dB between the two ears at more than one audiometric frequency up to 4 kHz; 4. native speaker of English; and 5. a score of at least 25 on the Mini Mental State Exam. Exclusion Criteria: 1. a conductive hearing impairment or other otological pathology; 2. chronic disease or use of medication that might affect the auditory system or the subject's ability to perform the experimental tasks; 3. an inability to perform the experimental tasks; 4. 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 5. experience with hearing aids prior to the study. Potential subjects meeting criterion 4 (contraindications for fMRI) will remain eligible to complete the non-MRI components of the trial (all visits other than V3, V10). These will be included in a Intent to Treat (ITT) cohort. Additional subjects who are eligible for MRI will be recruited into a Per Protocol (PP) cohort until the PP cohort meets target for total sample size (N = 60).
Where this trial is running
Loma Linda, California and 2 other locations
- VA Loma Linda Healthcare System, Loma Linda, CA — Loma Linda, California, United States (Recruiting)
- VA Greater Los Angeles Healthcare System, Sepulveda, CA — Sepulveda, California, United States (Not_yet_recruiting)
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles, California, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Jonathan Venezia, PhD — VA Loma Linda Healthcare System, Loma Linda, CA
- Study coordinator: Jonathan Venezia, PhD
- Email: Jonathan.Venezia@va.gov
- Phone: (909) 825-7084
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.