Comparing Hearing Aid Fitting Methods in Blast-exposed Veterans
SBA
Benefits of Speech-based Audiometry and Low-gain Hearing Aids for Blast-exposed Veterans
2 other identifiers
interventional
80
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2024
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2024
CompletedFirst Posted
Study publicly available on registry
March 13, 2024
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
April 14, 2026
April 1, 2026
4 years
March 5, 2024
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Modified Quick Speech-in-Noise Test (mQuickSIN) Score at 6 weeks
Participants repeat back sentences embedded in four-talker babble, with each sentence presented at one of six signal-to-noise ratios decreasing from 33.5 dB to 8.5 dB in 5 dB steps. Each sentence is scored for number of correct keywords (out of five) and the total number correct over six sentences is subtracted by a normative value of 25.5 to obtain the "signal-to-noise ratio loss." The average signal-to-noise ratio loss across two sets of six sentences is obtained. The target sentences are time-compressed by 66% and subject to simulated room reverberation (0.25 s reverberation time). The outcome is the aided vs. unaided difference across all measurement time points (within-subject). The effect of hearing aid fitting method (conventional, speech-based) is obtained between-subjects. The effect of hearing aid acclimatization is the between-subject difference (daily use group vs. no daily use group) in the change of the aided vs. unaided difference at 6 weeks.
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).
Abbreviated Profile of Hearing Aid Benefit (APHAB)
The APHAB is a validated questionnaire that measures subjective levels of listening difficulty pre and post hearing aid fitting in persons with hearing loss. The APHAB has been used to quantify subjective benefits of low-gain hearing aids in Service members with FHDs. The APHAB will be completed at the end of the study by participants assigned to use their hearing aids daily. The primary subjective study outcome is the aided vs. unaided difference in APHAB global score, obtained within-subject at a single time point (end of the final week of the six-week acclimatization period). The effect of hearing aid fitting method (conventional, speech-based) is obtained between-subjects.
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).
Secondary Outcomes (1)
Change in Digits in Noise Test (DIN) Score at Weekly Intervals from Baseline to 6 weeks
Baseline (pre-intervention; V4), once per week during the hearing aid intervention period (V5, V6, V7, V8, V9), and once at the end of the final week of the 6-week hearing aid intervention (V11). Results will be reported through study completion, on aver
Other Outcomes (1)
Change in fMRI Activation at 6 weeks
Assessed at baseline (pre-intervention; V3) and at the end of the final week of the 6-week hearing aid intervention (V10). Results will be reported through study completion, on average once per year (aligned with the RPPR).
Study Arms (2)
Speech-based hearing aid fitting
EXPERIMENTALHalf 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.
Audiogram-based hearing aid fitting
ACTIVE COMPARATORHalf 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.
Interventions
FDA approved hearing aid with gain settings determined either by speech-based audiometry or conventional fitting methods (NAL-NL2). Other features such as noise reduction and directional microphones are disabled for the duration of the study.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- a conductive hearing impairment or other otological pathology;
- 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.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VA Office of Research and Developmentlead
- University of California, San Diegocollaborator
- NADI Inc.collaborator
Study Sites (3)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Venezia, PhD
VA Loma Linda Healthcare System, Loma Linda, CA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Factor 1 is single blind: Participants will not know which procedure is used to program their hearing aid, but the investigator/outcomes assessor will. Factor 2 is unblinded: Participants will know whether they are assigned to the daily hearing aid use group.
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2024
First Posted
March 13, 2024
Study Start
April 1, 2024
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
March 31, 2028
Last Updated
April 14, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- The Protocol, SAP, and ICF will be uploaded to clinicaltrials.gov prior to initiation of data collection. The CSR and Analytic Code will be uploaded within one year of the study end date. All of the above documents are expected to remain available for as long as the relevant web servers continue operating. LDS with IPD will become available within one year of the study end date and only upon request from a qualifying investigator or institution. The LDS will be available until destruction of identifiable data is mandated according to the VA Record Control Schedule.
- Access Criteria
- Sharing of LDS containing IPD requires full execution of a DUA between the VA Loma Linda Healthcare System and the requesting investigator/institution.
A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. Any IPD transmitted pursuant to a DUA will be coded using unique alphanumeric strings that are linked to the identity of individual subjects only in the master logbook stored at the primary site (VA Loma Linda Healthcare System). The Protocol, SAP, ICF, and CSR will be uploaded to clinicaltrials.gov following the Protocol Registration and Results System (PRS) procedures. Analytic code will be posted to the Open Science Framework under a unique study code registered to the PI (Dr. Venezia). This will include all code necessary to implement/collect the proposed outcome measures and to reproduce anonymous data elements (e.g., summary figures and tables) used in publications.