Design and Methods of the Early Age-Related Hearing Loss Investigation Randomized Controlled Trial

被引：2

作者：

Denham, Michael W. ^{[1
]}

Arnold, Michelle L. ^{[2
]}

Sanchez, Victoria A. ^{[3
]}

Lin, Frank R. ^{[4
,5
,6
,7
]}

Gomez, Michael C. ^{[1
]}

Neil, Haley ^{[3
]}

Boyle, Suzannah ^{[3
]}

Selevan, Sally ^{[2
]}

Sussman, Tamara J. ^{[1
]}

Fine, Ione ^{[8
]}

Glynn, Nancy W. ^{[9
]}

Teresi, Jeanne ^{[10
,11
]}

Noble, James M. ^{[12
,13
]}

Goldberg, Terry ^{[14
,15
]}

Luchsinger, Jose A. ^{[16
]}

Golub, Justin S. ^{[1
,17
]}

机构：

[1] Columbia Univ, Irving Med Ctr, Dept Otolaryngol Head & Neck Surg, Vagelos Coll Phys & Surg, New York, NY USA

[2] Univ S Florida, Coll Behav & Community Sci, Dept Commun Sci & Disorders, Tampa, FL USA

[3] Univ S Florida, Dept Otolaryngol Head & Neck Surg, Tampa, FL USA

[4] Johns Hopkins Cochlear Ctr Hearing & Publ Hlth, Baltimore, MD USA

[5] Johns Hopkins Bloomberg Sch Publ Hlth, Dept Epidemiol, Baltimore, MD USA

[6] Johns Hopkins Sch Med, Dept Otolaryngol, Baltimore, MD USA

[7] Columbia Univ, New York State Psychiat Inst, Ctr Intergenerat Psychiat, Div Child Psychiat,Irving Med Ctr, New York, NY USA

[8] Univ Washington, Dept Psychol, Ctr Human Neurosci, Seattle, WA USA

[9] Univ Pittsburgh, Dept Epidemiol, Pittsburgh, PA USA

[10] Columbia Univ, New York State Psychiat Inst, Stroud Ctr, New York, NY USA

[11] Columbia Univ, Dept Med, New York, NY USA

[12] Columbia Univ, GH Sergievsky Ctr, Dept Neurol, New York, NY USA

[13] Columbia Univ, Taub Inst Res Alzheimers Dis & Aging Brain, New York, NY USA

[14] New York State Psychiat Inst & Hosp, Dept Psychiat, New York, NY USA

[15] Columbia Univ, Irving Med Ctr, New York, NY USA

[16] Columbia Univ, Dept Med, Irving Med Ctr, New York, NY USA

[17] Columbia Univ, Irving Med Ctr, Vagelos Coll Phys & Surg, Dept Otolaryngol Head & Neck Surg,Otol Neurotol &, 180 Ft Washington Ave,HP8, New York, NY 10032 USA

来源：

OTOLOGY & NEUROTOLOGY | 2024年 / 45卷 / 05期

关键词：

Clinical trials; Cognition; Dementia; Hearing intervention; Hearing loss; Memory; Presbycusis; COGNITIVE DECLINE; OLDER-ADULTS; DEMENTIA PREVENTION; INCIDENT DEMENTIA; SOCIAL ENGAGEMENT; ASSOCIATION; LONELINESS; IMPAIRMENT; INTERVENTION; POPULATION;

D O I：

10.1097/MAO.0000000000004093

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

ObjectiveHearing loss has been identified as a major modifiable risk factor for cognitive decline. The Early Age-Related Hearing Loss Investigation (EARHLI) study will assess the mechanisms linking early age-related hearing loss (ARHL) and cognitive impairment.Study DesignRandomized, controlled, single-site, early phase II, superiority trial.SettingTertiary academic medical center.ParticipantsOne hundred fifty participants aged 55 to 75 years with early ARHL (severity defined as borderline to moderate) and amnestic mild cognitive impairment will be included.InterventionsParticipants will be randomized 1:1 to a best practice hearing intervention or a health education control.Main Outcome MeasuresThe primary study outcome is cognition measured by the Alzheimer Disease Cooperative Study-Preclinical Alzheimer Cognitive Composite. Secondary outcomes include additional measures of cognition, social engagement, and brain organization/connectivity.ResultsTrial enrollment will begin in early 2024.ConclusionsAfter its completion in 2028, the EARHLI trial should offer evidence on the effect of hearing treatment versus a health education control on cognitive performance, social engagement, and brain organization/connectivity in 55- to 75-year-old community-dwelling adults with early ARHL and amnestic mild cognitive impairment.

引用

页码：594 / 601

页数：8

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