Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology · 2024
Design and Methods of the Early Age-Related Hearing Loss Investigation Randomized Controlled Trial.
СтатьяПоддержка NIH: внешняя программаПоддержка исследования: вне правительства СШАПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Denham Michael W, Arnold Michelle L, Sanchez Victoria A, Lin Frank R, Tucker Lauren H, Gomez Michael C, Fernandez Karla, Arpi Pamela, Neil Haley, Boyle Suzannah, Selevan Sally, Sussman Tamara J, Gmelin Theresa, Fine Ione, Glynn Nancy W, Teresi Jeanne, Noble James M, Goldberg Terry, Luchsinger Jose A, Golub Justin S
Аннотация
OBJECTIVE: Hearing 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 DESIGN: Randomized, controlled, single-site, early phase II, superiority trial.
SETTING: Tertiary academic medical center.
PARTICIPANTS: One 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.
INTERVENTIONS: Participants will be randomized 1:1 to a best practice hearing intervention or a health education control.
MAIN OUTCOME MEASURES: The 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.
RESULTS: Trial enrollment will begin in early 2024.
CONCLUSIONS: After 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.
STUDY DESIGN: Randomized, controlled, single-site, early phase II, superiority trial.
SETTING: Tertiary academic medical center.
PARTICIPANTS: One 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.
INTERVENTIONS: Participants will be randomized 1:1 to a best practice hearing intervention or a health education control.
MAIN OUTCOME MEASURES: The 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.
RESULTS: Trial enrollment will begin in early 2024.
CONCLUSIONS: After 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.