protocolSection identificationModule nctId: NCT06309264, orgStudyIdInfo id: C5059-R, secondaryIdInfos id: I01RX005059, type: NIH, link: https://reporter.nih.gov/quickSearch/I01RX005059, briefTitle: Comparing Hearing Aid Fitting Methods in Blast-exposed Veterans, acronym: SBA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2028-03-31, completionDateStruct date: 2028-03-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: VA Office of Research and Development, class: FED, collaborators name: University of California, San Diego, collaborators name: NADI Inc., descriptionModule briefSummary: 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., conditionsModule conditions: Auditory Diseases, Central, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: This study is a 2x2 randomized trial. Each subject receives a low-gain hearing aid. The randomized factors are:1. Fitting method. Half of the subjects have their hearing aids programmed using conventional methods based on the pure-tone audiogram. The remainder have their hearing aids programmed using the gain profile selected from speech-based audiometry.2. Daily hearing aid use. Half of the subjects will be assigned to use their hearing aids routinely in daily life for a six-week acclimatization period. The remaining half will be followed for the same six-week period but will use their hearing aids only to complete pre-post (mQuickSIN, fMRI) and weekly (DIN) laboratory assessments for speech recognition in noise. The daily use group will complete the same assessments.The factors are fully crossed such that there are four groups in the experiment., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: 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., whoMasked: PARTICIPANT, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Phonak Lumina P90, outcomesModule primaryOutcomes measure: Change in Modified Quick Speech-in-Noise Test (mQuickSIN) Score at 6 weeks, primaryOutcomes measure: Abbreviated Profile of Hearing Aid Benefit (APHAB), secondaryOutcomes measure: Change in Digits in Noise Test (DIN) Score at Weekly Intervals from Baseline to 6 weeks, otherOutcomes measure: Change in fMRI Activation at 6 weeks, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: VA Loma Linda Healthcare System, Loma Linda, CA, city: Loma Linda, state: California, zip: 92357-1000, country: United States, contacts name: Maria I Rodriguez, role: CONTACT, phone: 909-583-6050, email: maria.Rodriguez9@va.gov, contacts name: Ernest M Alva, role: CONTACT, phone: (909) 825-7084, phoneExt: 1500, email: ernest.alva@va.gov, contacts name: Jonathan Venezia, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.04835, lon: -117.26115, locations facility: VA Greater Los Angeles Healthcare System, Sepulveda, CA, city: Sepulveda, state: California, zip: 91343, country: United States, contacts name: Delia Karahalios, AuD, role: CONTACT, phone: 818-891-7711, phoneExt: 32752, email: delia.karahalios@va.gov, contacts name: Jamie Spector, AuD, role: CONTACT, phone: 8188917711, phoneExt: 7062, email: jamie.spector@va.gov, geoPoint lat: 34.16167, lon: -118.28285, locations facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA, city: West Los Angeles, state: California, zip: 90073-1003, country: United States, contacts name: Delia Karahalios, AuD, role: CONTACT, phone: 818-891-7711, phoneExt: 32752, email: delia.karahalios@va.gov, contacts name: Guneet Missan, AuD, role: CONTACT, phone: 3104783711, phoneExt: 40613, email: guneet.missan@va.gov, geoPoint lat: 34.0464, lon: -118.44813, hasResults: False