Comparing hearing aid fitting methods for veterans exposed to blasts

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.