Publications

BACKGROUND: Blast exposure is a major source of injury among Service members in the Iraq and Afghanistan conflicts. Many of these blast-exposed veterans report hearing-related problems such as difficulties understanding speech in noise and rapid speech, and following instructions and long conversations that are disproportionate to their measured peripheral hearing sensitivity. Evidence is mounting that these complaints result from damage to the central auditory processing system.

PURPOSE: To evaluate the effectiveness of audiological rehabilitative interventions for blast-exposed veterans with normal or near-normal peripheral hearing and functional hearing difficulties.

RESEARCH DESIGN: A randomized controlled trial with four intervention arms.

STUDY SAMPLE: Ninety-nine blast-exposed veterans with normal or near-normal peripheral hearing who reported functional hearing difficulties.

INTERVENTION: Four interventions were compared: compensatory communication strategies (CCS) education, CCS and use of a personal frequency modulation system (FM + CCS), CCS and use of an auditory training program (AT + CCS), and use of all three interventions combined (FM + AT + CCS).

DATA COLLECTION AND ANALYSIS: All participants tested before, and immediately following an 8-week intervention period. The primary outcome measures upon which the study was powered assessed speech understanding in noise and self-reported psychosocial impacts of the intervention. In addition, auditory temporal processing, auditory working memory, allocation of attention, and hearing and cognitive self-report outcomes were assessed.

RESULTS: Use of FM + CCS resulted in significant benefit for speech understanding in noise and self-reported hearing benefits, and FM + AT + CCS provided more self-reported cognitive benefits than FM + CCS, AT + CCS, or CCS. Further, individuals liked and reported using the FM system, but there was poor adherence to and high attrition among individuals assigned to receive AT.

CONCLUSIONS: It is concluded that a FM system (or remote microphone via Bluetooth system) is an effective intervention for blast-exposed veterans with normal or near-normal hearing and functional hearing difficulties and should be routinely considered as an intervention approach for this population when possible.

INTRODUCTION: Hearing impairment is highly prevalent and independently associated with cognitive decline. The Aging and Cognitive Health Evaluation in Elders study is a multicenter randomized controlled trial to determine efficacy of hearing treatment in reducing cognitive decline in older adults. Clinicaltrials.gov Identifier: NCT03243422.

METHODS: Eight hundred fifty participants without dementia aged 70 to 84 years with mild-to-moderate hearing impairment recruited from four United States field sites and randomized 1:1 to a best-practices hearing intervention or health education control. Primary study outcome is 3-year change in global cognitive function. Secondary outcomes include domain-specific cognitive decline, incident dementia, brain structural changes on magnetic resonance imaging, health-related quality of life, physical and social function, and physical activity.

RESULTS: Trial enrollment began January 4, 2018 and is ongoing.

DISCUSSION: When completed in 2022, Aging and Cognitive Health Evaluation in Elders study should provide definitive evidence of the effect of hearing treatment versus education control on cognitive decline in community-dwelling older adults with mild-to-moderate hearing impairment.

OBJECTIVE: Recruiting into clinical trials on time and on target is a major challenge and yet often goes unreported. This study evaluated the adjustment to procedures, recruitment and screening methods in two multi-centre pharmaceutical randomised controlled trials (RCTs) for hearing-related problems in adults.

DESIGN: Recruitment monitoring and subsequent adjustment of various study procedures (e.g. eligibility criteria, increasing recruiting sites and recruitment methods) are reported. Participants were recruited through eight overarching methods: trial registration, posters/flyers, print publications, Internet, social media, radio, databases and referrals. The efficiency of the recruitment was measured by determining the number of people: (1) eligible for screening as a percentage of those who underwent telephone pre-screening and (2) randomised as a percentage of those screened.

STUDY SAMPLE: A total of 584 participants completed the pre-screening steps, 491 screened and 169 participants were randomised.

RESULTS: Both RCTs completed adjustments to the participant eligibility, added new study sites and additional recruitment methods. No single recruitment method was efficient enough to serve as the only route to enrolment.

CONCLUSION: A diverse portfolio of methods, continuous monitoring, mitigation strategy and adequate resourcing were essential for achieving our recruitment goals.

INTRODUCTION: Hearing loss (HL) is prevalent and independently related to cognitive decline and dementia. There has never been a randomized trial to test if HL treatment could reduce cognitive decline in older adults.

METHODS: A 40-person (aged 70-84 years) pilot study in Washington County, MD, was conducted. Participants were randomized 1:1 to a best practices hearing or successful aging intervention and followed for 6 months. clinicaltrials.gov Identifier: NCT02412254.

RESULTS: The Aging and Cognitive Health Evaluation in Elders Pilot (ACHIEVE-P) Study demonstrated feasibility in recruitment, retention, and implementation of interventions with no treatment-related adverse events. A clear efficacy signal of the hearing intervention was observed in perceived hearing handicap (mean of 0.11 to -1.29 standard deviation [SD] units; lower scores better) and memory (mean of -0.10 SD to 0.38 SD).

DISCUSSION: ACHIEVE-P sets the stage for the full-scale ACHIEVE trial (N = 850, recruitment beginning November 2017), the first randomized trial to determine efficacy of a best practices hearing (vs. successful aging) intervention on reducing cognitive decline in older adults with HL.

Age-related hearing loss affects nearly thirty million older adults in the United States and is associated with increased risk of several other adverse health outcomes. Although hearing aids are the most common efficacious treatment, Medicaid coverage of the aids is not federally mandated, and cost has been cited as a barrier to access. In this first (to our knowledge) comprehensive review of state-level Medicaid coverage of hearing aids and associated services for age-related hearing loss, we found that twenty-eight states offer some degree of coverage-which varies substantially with respect to extent and hearing loss eligibility requirements. Based on six criteria, we rated those states' coverage as fair, good, or excellent. The remaining twenty-two states have no coverage, which leaves few options for their residents with hearing loss who face financial constraints. Policy makers at the state and federal levels should consider how to make care for age-related hearing loss more accessible, affordable, and equitable nationwide.

INTRODUCTION: Hearing loss (HL) is prevalent and independently related to cognitive decline and dementia. There has never been a randomized trial to test if HL treatment could reduce cognitive decline in older adults.

METHODS: A 40-person (aged 70-84 years) pilot study in Washington County, MD, was conducted. Participants were randomized 1:1 to a best practices hearing or successful aging intervention and followed for 6 months. clinicaltrials.gov Identifier: NCT02412254.

RESULTS: The Aging and Cognitive Health Evaluation in Elders Pilot (ACHIEVE-P) Study demonstrated feasibility in recruitment, retention, and implementation of interventions with no treatment-related adverse events. A clear efficacy signal of the hearing intervention was observed in perceived hearing handicap (mean of 0.11 to -1.29 standard deviation [SD] units; lower scores better) and memory (mean of -0.10 SD to 0.38 SD).

DISCUSSION: ACHIEVE-P sets the stage for the full-scale ACHIEVE trial (N = 850, recruitment beginning November 2017), the first randomized trial to determine efficacy of a best practices hearing (vs. successful aging) intervention on reducing cognitive decline in older adults with HL.

OBJECTIVE: To examine the effectiveness of the Listening and Communication Enhancement (LACE) program as a supplement to standard-of-care hearing aid intervention in a Veteran population.

DESIGN: A multisite randomized controlled trial was conducted to compare outcomes following standard-of-care hearing aid intervention supplemented with (1) LACE training using the 10-session DVD format, (2) LACE training using the 20-session computer-based format, (3) placebo auditory training (AT) consisting of actively listening to 10 hr of digitized books on a computer, and (4) educational counseling-the control group. The study involved 3 VA sites and enrolled 279 veterans. Both new and experienced hearing aid users participated to determine if outcomes differed as a function of hearing aid user status. Data for five behavioral and two self-report measures were collected during three research visits: baseline, immediately following the intervention period, and at 6 months postintervention. The five behavioral measures were selected to determine whether the perceptual and cognitive skills targeted in LACE training generalized to untrained tasks that required similar underlying skills. The two self-report measures were completed to determine whether the training resulted in a lessening of activity limitations and participation restrictions. Outcomes were obtained from 263 participants immediately following the intervention period and from 243 participants 6 months postintervention. Analyses of covariance comparing performance on each outcome measure separately were conducted using intervention and hearing aid user status as between-subject factors, visit as a within-subject factor, and baseline performance as a covariate.

RESULTS: No statistically significant main effects or interactions were found for the use of LACE on any outcome measure.

CONCLUSIONS: Findings from this randomized controlled trial show that LACE training does not result in improved outcomes over standard-of-care hearing aid intervention alone. Potential benefits of AT may be different than those assessed by the performance and self-report measures utilized here. Individual differences not assessed in this study should be examined to evaluate whether AT with LACE has any benefits for particular individuals. Clinically, these findings suggest that audiologists may want to temper the expectations of their patients who embark on LACE training.

PURPOSE: The purpose of this study was to determine if patient characteristics or clinical variables could predict who benefits from individual auditory training.

METHOD: A retrospective series of analyses were performed using a data set from a large, multisite, randomized controlled clinical trial that compared the treatment effects of at-home auditory training programs in bilateral hearing aid users. The treatment arms were (a) use of the 20-day computerized Listening and Communication Enhancement program, (b) use of the 10-day digital versatile disc Listening and Communication Enhancement program, (c) use of a placebo "books-on-tape" training, and (d) educational counseling (active control). Multiple linear regression models using data from 263 participants were conducted to determine if patient and clinical variables predicted short-term improvement on word-recognition-in-noise abilities, self-reported hearing handicap, and self-reported hearing problems.

RESULTS: Baseline performance significantly predicted performance on each variable, explaining 11%-17% of the variance in improvement. The treatment arm failed to emerge as a significant predictor with other clinical variables explaining less than 9% of the variance.

CONCLUSION: These results suggest that hearing aid users who have poorer aided word-recognition-in-noise scores and greater residual activity limitations and participation restrictions will show the largest improvement in these areas.