Benefits of Speech-based Audiometry and Low-gain Hearing Aids for Blast-exposed Veterans

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

⁃ 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:

• 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.

Locations
United States
California
VA Loma Linda Healthcare System, Loma Linda, CA
RECRUITING
Loma Linda
VA Greater Los Angeles Healthcare System, Sepulveda, CA
NOT_YET_RECRUITING
Sepulveda
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
NOT_YET_RECRUITING
West Los Angeles
Contact Information
Primary
Jonathan Venezia, PhD
Jonathan.Venezia@va.gov
(909) 825-7084
Backup
Akai R McKinley, BA
Akai.McKinley@va.gov
(909) 825-7084
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 80
Treatments
Experimental: Speech-based hearing aid fitting
Half of the study participants receive a hearing aid with gain settings determined via speech-based audiometry. Other hearing aid features such as noise reduction and directional microphones are disabled. Of this group of subjects, half are assigned to use the hearing aid daily for six weeks, while the remainder are followed for the same six-week period but use their hearing aids only to complete outcomes testing.
Active_comparator: Audiogram-based hearing aid fitting
Half of the study participants receive a hearing aid with gain settings determined by applying the NAL-NL2 prescriptive formula to the pure-tone audiogram. Other hearing aid features such as noise reduction and directional microphones are disabled. Of this group of subjects, half are assigned to use the hearing aid daily for six weeks, while the remainder are followed for the same six-week period but use their hearing aids only to complete outcomes testing.
Related Therapeutic Areas
Sponsors
Collaborators: University of California, San Diego, NADI Inc.
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov