Benefits of Speech-based Audiometry and Low-gain Hearing Aids for Blast-exposed Veterans
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- Abbreviated Profile of Hearing Aid Benefit (APHAB)
研究概览
简要总结
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.
详细描述
The present study is a randomized trial of low-gain hearing aids in blast-exposed Veterans with normal or near-normal audiometric hearing and self-reported functional hearing difficulties. Hearing aids will be programmed using either conventional methods or a novel procedure called speech-based audiometry. Participants will be randomized into different groups receiving conventional or speech-based programming. Participants will be followed for a six-week intervention period and complete several outcome measures before, during, and after the intervention period. Each group will be further divided, at random, into equal subgroups assigned to (i) use their hearing aid daily during the six-week intervention period or (ii) use their hearing aid only to complete the outcomes assessments. The study will be broken into five periods:
- Prescreening, screening, and enrollment
- Preparatory period
- Baseline
- Treatment (first five weeks of hearing aid intervention)
- Follow-up (final week of hearing aid intervention)
Prescreening, screening, enrollment (V0).
Prescreening includes identification of potential participants via medical record search, examination of patient rolls, clinician referral, or patient self-referral (e.g., from study advertisements). A prescreening phone call or in-person prescreening visit is scheduled for willing participants.
At the time of the in-person prescreening or prescreening phone call, a script will be used to learn if prospective participants meet basic eligibility criteria and are able to present for an in-person discussion of informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Phonak Lumina P90 (Device)
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.
干预措施: Phonak Lumina P90 (Device)
结局指标
主要结局
Abbreviated Profile of Hearing Aid Benefit (APHAB)
时间窗: 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).
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.
Change in Modified Quick Speech-in-Noise Test (mQuickSIN) Score at 6 weeks
时间窗: 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).
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.
次要结局
- 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)