RECRUITING

Comparing Hearing Aid Fitting Methods in Blast-exposed Veterans

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-01
Study Completion:2028-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06309264

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. pure-tone average (PTA) at 0.5, 1, 2, 4 kHz of 35 dB HL or better in each ear;
  2. 2. pure-tone thresholds no worse than 40 dB HL at any two audiometric frequencies up to 8 kHz;
  3. 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. 4. native speaker of English; and
  5. 5. a score of at least 25 on the Mini Mental State Exam.
  1. 1. a conductive hearing impairment or other otological pathology;
  2. 2. chronic disease or use of medication that might affect the auditory system or the subject's ability to perform the experimental tasks;
  3. 3. an inability to perform the experimental tasks;
  4. 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. 5. experience with hearing aids prior to the study.

Contacts and Locations

Study Contact

Jonathan Venezia, PhD
CONTACT
(909) 825-7084
Jonathan.Venezia@va.gov
Kelli J Sugai, BA
CONTACT
(909) 825-7084
kelli.sugai@va.gov

Principal Investigator

Jonathan Venezia, PhD
PRINCIPAL_INVESTIGATOR
VA Loma Linda Healthcare System, Loma Linda, CA

Study Locations (Sites)

VA Loma Linda Healthcare System, Loma Linda, CA
Loma Linda, California, 92357-1000
United States
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, 91343
United States
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Jonathan Venezia, PhD, PRINCIPAL_INVESTIGATOR, VA Loma Linda Healthcare System, Loma Linda, CA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-01
Study Completion Date2028-03-31

Study Record Updates

Study Start Date2024-04-01
Study Completion Date2028-03-31

Terms related to this study

Keywords Provided by Researchers

  • blast injuries
  • occupational exposure
  • auditory diseases, central
  • hearing loss, hidden
  • hearing loss
  • hearing aids
  • hearing disorders
  • hearing loss, central
  • auditory perceptual disorders
  • correction of hearing impairment

Additional Relevant MeSH Terms

  • Auditory Diseases, Central