Publications by Year: 2018

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.

PURPOSE: The aims of the study were to compare the Cognitive Self-Report Questionnaire (CSRQ; Spina, Ruff, & Mahncke, 2006) Hearing and Cognitive subscale ratings among older adults with and without probable mild cognitive impairment (MCI) and to examine whether self-report, as measured by the CSRQ, is associated with objective measures of hearing, auditory processing, and cognition.

METHOD: Data analyses included 97 older adults of ages 61-91 years. Participants completed the CSRQ self-report measure as well as a battery of objective measures, including pure-tone audiometry, degraded speech understanding, temporal processing, and memory.

RESULTS: Older adults with probable MCI rated their cognitive abilities more poorly than those without MCI (p = .002), but ratings of hearing and auditory abilities did not differ between the two groups (p = .912). Age and CSRQ Hearing subscale ratings explained a significant proportion of variance in objective measures of hearing and degraded speech understanding (R2 = .39, p < .001). Age, sex, mental status, and CSRQ Cognition subscale ratings explained a significant proportion of variance in objective memory performance (R2 = .55, p < .001).

CONCLUSIONS: Taken together, these results suggest that the CSRQ is an appropriate self-report measure of hearing, cognition, and some aspects of auditory processing for older adults with and without probable MCI.

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.

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.