Randomized Controlled Trial

. 2023 Sep 2;402(10404):786-797.

doi: 10.1016/S0140-6736(23)01406-X. Epub 2023 Jul 18.

Hearing intervention versus health education control to reduce cognitive decline in older adults with hearing loss in the USA (ACHIEVE): a multicentre, randomised controlled trial

Frank R Lin¹, James R Pike², Marilyn S Albert³, Michelle Arnold⁴, Sheila Burgard⁵, Theresa Chisolm⁴, David Couper⁵, Jennifer A Deal⁶, Adele M Goman⁷, Nancy W Glynn⁸, Theresa Gmelin⁸, Lisa Gravens-Mueller⁵, Kathleen M Hayden⁹, Alison R Huang¹⁰, David Knopman¹¹, Christine M Mitchell², Thomas Mosley¹², James S Pankow¹³, Nicholas S Reed⁶, Victoria Sanchez¹⁴, Jennifer A Schrack¹⁵, B Gwen Windham¹², Josef Coresh²; ACHIEVE Collaborative Research Group

Affiliations

¹ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Department of Otolaryngology-Head & Neck Surgery, Johns Hopkins School of Medicine, Baltimore, MD, USA; Center on Aging and Health, Johns Hopkins University, Baltimore, MD, USA. Electronic address: flin1@jh.edu.
² Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
³ Department of Neurology, Johns Hopkins School of Medicine, Baltimore, MD, USA.
⁴ Department of Communication Sciences & Disorders, College of Behavioral & Community Sciences, University of South Florida, Tampa, FL, USA.
⁵ Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.
⁶ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Department of Otolaryngology-Head & Neck Surgery, Johns Hopkins School of Medicine, Baltimore, MD, USA.
⁷ School of Health and Social Care, Edinburgh Napier University, Edinburgh, UK.
⁸ Department of Epidemiology, University of Pittsburgh School of Public Health, Pittsburgh, PA, USA.
⁹ Department of Social Sciences and Health Policy, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
¹⁰ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
¹¹ Department of Neurology, Mayo Clinic, Rochester, MN, USA.
¹² The MIND Center, University of Mississippi Medical Center, Jackson, MS, USA.
¹³ Division of Epidemiology and Community Health, University of Minnesota School of Public Health, Minneapolis, MN, USA.
¹⁴ Department of Otolaryngology-Head & Neck Surgery, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.
¹⁵ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Center on Aging and Health, Johns Hopkins University, Baltimore, MD, USA.

PMID: 37478886
PMCID: PMC10529382
DOI: 10.1016/S0140-6736(23)01406-X

Randomized Controlled Trial

Hearing intervention versus health education control to reduce cognitive decline in older adults with hearing loss in the USA (ACHIEVE): a multicentre, randomised controlled trial

Frank R Lin et al. Lancet. 2023.

. 2023 Sep 2;402(10404):786-797.

doi: 10.1016/S0140-6736(23)01406-X. Epub 2023 Jul 18.

Authors

Affiliations

¹ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Department of Otolaryngology-Head & Neck Surgery, Johns Hopkins School of Medicine, Baltimore, MD, USA; Center on Aging and Health, Johns Hopkins University, Baltimore, MD, USA. Electronic address: flin1@jh.edu.
² Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
³ Department of Neurology, Johns Hopkins School of Medicine, Baltimore, MD, USA.
⁴ Department of Communication Sciences & Disorders, College of Behavioral & Community Sciences, University of South Florida, Tampa, FL, USA.
⁵ Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.
⁶ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Department of Otolaryngology-Head & Neck Surgery, Johns Hopkins School of Medicine, Baltimore, MD, USA.
⁷ School of Health and Social Care, Edinburgh Napier University, Edinburgh, UK.
⁸ Department of Epidemiology, University of Pittsburgh School of Public Health, Pittsburgh, PA, USA.
⁹ Department of Social Sciences and Health Policy, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
¹⁰ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
¹¹ Department of Neurology, Mayo Clinic, Rochester, MN, USA.
¹² The MIND Center, University of Mississippi Medical Center, Jackson, MS, USA.
¹³ Division of Epidemiology and Community Health, University of Minnesota School of Public Health, Minneapolis, MN, USA.
¹⁴ Department of Otolaryngology-Head & Neck Surgery, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.
¹⁵ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Center on Aging and Health, Johns Hopkins University, Baltimore, MD, USA.

PMID: 37478886
PMCID: PMC10529382
DOI: 10.1016/S0140-6736(23)01406-X

Abstract

Background: Hearing loss is associated with increased cognitive decline and incident dementia in older adults. We aimed to investigate whether a hearing intervention could reduce cognitive decline in cognitively healthy older adults with hearing loss.

Methods: The ACHIEVE study is a multicentre, parallel-group, unmasked, randomised controlled trial of adults aged 70-84 years with untreated hearing loss and without substantial cognitive impairment that took place at four community study sites across the USA. Participants were recruited from two study populations at each site: (1) older adults participating in a long-standing observational study of cardiovascular health (Atherosclerosis Risk in Communities [ARIC] study), and (2) healthy de novo community volunteers. Participants were randomly assigned (1:1) to a hearing intervention (audiological counselling and provision of hearing aids) or a control intervention of health education (individual sessions with a health educator covering topics on chronic disease prevention) and followed up every 6 months. The primary endpoint was 3-year change in a global cognition standardised factor score from a comprehensive neurocognitive battery. Analysis was by intention to treat. This trial was registered at ClinicalTrials.gov, NCT03243422.

Findings: From Nov 9, 2017, to Oct 25, 2019, we screened 3004 participants for eligibility and randomly assigned 977 (32·5%; 238 [24%] from ARIC and 739 [76%] de novo). We randomly assigned 490 (50%) to the hearing intervention and 487 (50%) to the health education control. The cohort had a mean age of 76·8 years (SD 4·0), 523 (54%) were female, 454 (46%) were male, and most were White (n=858 [88%]). Participants from ARIC were older, had more risk factors for cognitive decline, and had lower baseline cognitive scores than those in the de novo cohort. In the primary analysis combining the ARIC and de novo cohorts, 3-year cognitive change (in SD units) was not significantly different between the hearing intervention and health education control groups (-0·200 [95% CI -0·256 to -0·144] in the hearing intervention group and -0·202 [-0·258 to -0·145] in the control group; difference 0·002 [-0·077 to 0·081]; p=0·96). However, a prespecified sensitivity analysis showed a significant difference in the effect of the hearing intervention on 3-year cognitive change between the ARIC and de novo cohorts (p_interaction=0·010). Other prespecified sensitivity analyses that varied analytical parameters used in the total cohort did not change the observed results. No significant adverse events attributed to the study were reported with either the hearing intervention or health education control.

Interpretation: The hearing intervention did not reduce 3-year cognitive decline in the primary analysis of the total cohort. However, a prespecified sensitivity analysis showed that the effect differed between the two study populations that comprised the cohort. These findings suggest that a hearing intervention might reduce cognitive change over 3 years in populations of older adults at increased risk for cognitive decline but not in populations at decreased risk for cognitive decline.

Funding: US National Institutes of Health.

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Conflict of interest statement

Declaration of interests FRL reports research grants from the US National Institutes of Health and Eleanor Schwartz Charitable Foundation; consulting fees from Frequency Therapeutics and Apple; payment for expert testimony and participation on a scientific advisory board for Fondation Pour L'Audition and Sharper Sense; being a volunteer board member for Access HEARS; donation in-kind from Sonova/Phonak to Johns Hopkins University for hearing technologies used in the present study; and being the director of a public health research centre funded in part by a philanthropic donation from Cochlear to the Johns Hopkins Bloomberg School of Public Health. KMH reports consulting fees from Fred Hutchinson Cancer Research Center; support for attending meetings (National Institute for Health Center for Scientific Review and Hebrew Senior Life); participation on the Wake Forest School of Medicine DSMB (unpaid); and leadership roles for peer-reviewed journals (Alzheimer's & Dementia: Translational Research and Clinical Interventions and Alzheimer's & Dementia: Diagnosis, and Assessment & Disease Monitoring [unpaid]). DK serves on a DSMB for the Dominantly Inherited Alzheimer Network Treatment Unit study. He served on a DSMB for a tau therapeutic for Biogen (until 2021) but received no personal compensation. He is an investigator in clinical trials sponsored by Biogen, Lilly Pharmaceuticals, and the University of Southern California. He has served as a consultant for Roche, Samus Therapeutics, Magellan Health, Biovie, and Alzeca Biosciences but receives no personal compensation. He attended an Eisai advisory board meeting for lecanemab on Dec 2, 2022, but received no compensation. VS reports industry-sponsored clinical research contract (to institution) to support research activity from Otonomy, Frequency Therapeutics, Pipeline Therapeutics, Aerin Medical, Oticon Medical, and Helen of Troy; consulting fees from Autifony Therapeutics and Boehringer Ingelheim; honoraria from Oticon Medical, Sonova Holding, and Phonak USA; and hearing technology devices donated for educational or research proposes from Sonova Holding and Phonak USA. MA reports consulting fees from GN Resound, National Institute on Deafness and Other Communication Disorder (NIDCD), and the National Institute on Aging (NIA); travel support from NIDCD and NIA; and receipt of equipment from Sonova. NSR reports being Editor of the American Journal of Audiology (paid) and Scientific Chair of the American Academy of Audiology, Advisory Board Member with stock options for Neosensory, and being a member of the Scientific Advisory Board for Shoebox. All other authors declare no competing interests.

Figures

**Figure 1.**
ACHIEVE Screening, Randomisation, and Follow-Up Abbreviations: ACHIEVE, Aging and Cognitive Health Evaluation in Elders; ARIC, Atherosclerosis Risk in Communities.

**Figure 2.**
Covariate-Adjusted Analysis of Three-Year Cognitive Change by Randomised Treatment Assignment Among the Total Cohort and Stratified by Recruitment Source (N=977) Symbols: *Statistically significant (p<·05) three-way interaction between randomisation, recruitment source, and time; ^ The analytic sample for the primary analysis comprised 977 in-person assessments from baseline, 862 in-person assessments from year 3 (203 ARIC, 659 De Novo), 9 in-person assessments (5 ARIC, 4 De Novo) from participants who died prior to year 3 but completed an assessment less than a year before death, and 106 missing year 3 assessments (30 ARIC, 76 De Novo) with values generated from a prespecified multiple imputation model. Abbreviations: ACHIEVE, Aging and Cognitive Health Evaluation in Elders; ARIC, Atherosclerosis Risk in Communities; CI, confidence intervals; SD, standard deviation. Parameter estimates, 95% confidence intervals, and p-values were calculated from a linear mixed effects models that adjusted for hearing loss (PTA <40 dB vs 40+ dB), recruitment source, field site, age, sex, education, and the presence of APOE e4 alleles at baseline. An interaction with time was specified for each covariate except education. A three-way interaction between randomisation, recruitment source, and time was tested for each model prior to stratification.

**Figure 3.**
Trajectories and Pointwise Estimates of Cognitive Function by Randomised Treatment Assignment Among the Total Cohort and Stratified by Recruitment Source (N=977) Symbols: *The analytic sample for the primary analysis comprised 977 in-person assessments from baseline, 862 in-person assessments from year 3 (203 ARIC, 659 De Novo), 9 in-person assessments (5 ARIC, 4 De Novo) from participants who died prior to year 3 but completed an assessment less than a year before death, and 106 missing year 3 assessments (30 ARIC, 76 De Novo) with values generated from a prespecified multiple imputation model. Abbreviations: ACHIEVE, Aging and Cognitive Health Evaluation in Elders; ARIC, Atherosclerosis Risk in Communities. Y-axis values are cognitive factor scores that were developed using a validated latent variable modeling approach15 and standardized to the baseline with higher scores indicating better cognitive function. Parameter estimates, 95% confidence intervals, and p-values were calculated from a linear mixed effects models that adjusted for hearing loss (PTA <40 dB vs 40+ dB), recruitment source, field site, age, sex, education, and the presence of APOE e4 alleles at baseline. An interaction with time was specified for each covariate except education. Visualization based on a hypothetical participant whose characteristics equalled the sample means. Δp refers to the p-value of the interaction between time and randomisation.

**Figure 4.**
Cumulative Incidence of Cognitive Impairment by Randomised Treatment Assignment Among the Total Cohort and Stratified by Recruitment Source (N=977) Abbreviations: ACHIEVE, Aging and Cognitive Health Evaluation in Elders; ARIC, Atherosclerosis Risk in Communities. Cumulative incidence curves depict the proportion of participants with cognitive impairment after accounting for the competing risk of death.

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Comment in

Interventions to prevent dementia should target those at high risk.
Livingston G, Costafreda SG. Livingston G, et al. Lancet. 2023 Sep 2;402(10404):750-751. doi: 10.1016/S0140-6736(23)01472-1. Epub 2023 Jul 18. Lancet. 2023. PMID: 37478885 No abstract available.
Hörgerät reduziert kognitiven Abbau bei Demenzrisiko.
von Arnim C. von Arnim C. MMW Fortschr Med. 2024 May;166(8):24-26. doi: 10.1007/s15006-024-3880-9. MMW Fortschr Med. 2024. PMID: 38693374 German. No abstract available.
Hearing intervention and cognitive decline: the ACHIEVE trial.
Terao T. Terao T. Lancet. 2024 Jul 6;404(10447):29. doi: 10.1016/S0140-6736(24)00711-6. Lancet. 2024. PMID: 38971589 No abstract available.
Hearing intervention and cognitive decline: the ACHIEVE trial.
Liu K. Liu K. Lancet. 2024 Jul 6;404(10447):29-30. doi: 10.1016/S0140-6736(24)00712-8. Lancet. 2024. PMID: 38971590 No abstract available.

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Hearing intervention versus health education control to reduce cognitive decline in older adults with hearing loss in the USA (ACHIEVE): a multicentre, randomised controlled trial

Affiliations

Hearing intervention versus health education control to reduce cognitive decline in older adults with hearing loss in the USA (ACHIEVE): a multicentre, randomised controlled trial

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