Strengthening the Ear-to-brain Connection in Older Adults With Hearing Loss Through Engaging Web-based Gamified Auditory-cognitive Dual-task Training: a Randomized Controlled Trial

Обзор

Abstract Objectives To assess the effectiveness of a web-based gamified auditory-cognitive dual-task training (ACDT) in improving the everyday listening abilities of older adults with hearing loss (HL), including speech perception performance, cognition, and self-reported hearing. Hypothesis to be tested ACDT participants will show significantly greater improvements in 1) self-reported hearing; 2) speech perception-in-noise; 3) attention; 4) reasoning; and 5) dual-task of listening and working memory compared to the control group at week 6, immediately post-intervention, and week 24. Design and subjects A prospective, single-blinded, two-arm parallel randomized controlled trial with individual semi-structured interviews. 164 Chinese adults aged 60 years or older, who speak Cantonese or Putonghua, and have mild-to-moderate HL with a pure-tone average of 20-50 dB across octave frequencies 0.5 to 4kHz in both ears. Study instruments A web-based gamified auditory-cognitive dual-task training. Interventions This is a 12-week program conducted five times a week, with each session lasting 60 minutes, following a sequential dual-task training design. Each session includes auditory training in speech-in-noise, rapid speech, and competing speaker, and cognitive training focusing on executive function, perceptual-motor ability, memory, and complex attention. Main outcome measures Self-reported hearing (untrained); Speech perception in noise (trained), attention in listening and sustained selective attention (trained), reasoning (trained), and dual-task of listening and working memory; complex span working memory (trained). Data analysis Descriptive statistics, an independent sample t-test or chi square test, generalized estimating equation and thematic analysis will be used. Expected results ACDT significantly improves the everyday listening abilities of older adults with HL.

Вмешательства

• Поведенческое Web-based gamified auditory-cognitive sequential dual-task training system
  The intervention is a 12-week sequential dual-task training program delivered five times per week for 60 minutes per session. Each session includes 5 minutes of volume adjustment and orientation exercises, 25 minutes of adaptive auditory training in speech-in-noise, rapid speech, and competing-speaker listening, 25 minutes of culturally tailored cognitive games targeting executive function, memory, attention, and perceptual-motor skills, and a 5-minute wrap-up with communication strategies and l
• Поведенческое Control
  Participants will be instructed to complete web-based Chinese crossword puzzles 60 minutes per day and five days a week. Medium difficulty level will be selected for participants according to previous research.

Первичные конечные точки

• Hearing Handicap Inventory for the Elderly [Срок оценки: at week 6, immediately post-intervention (week 12), and week 24]

Вторичные конечные точки (4)

• The Cantonese Hearing in Noise Test [Срок оценки: at week 6, immediately post-intervention (week 12), and week 24]
• The Chinese Auditory Verbal Learning Test [Срок оценки: at week 6, immediately post-intervention (week 12), and week 24]
• The Chinese Trial Making Test Part A& B [Срок оценки: at week 6, immediately post-intervention (week 12), and week 24]
• Dual task of listening and working memory [Срок оценки: at week 6, immediately post-intervention (week 12), and week 24]

Критерии участия

Критерии включения

• Ethnic Chinese aged 60 years and above, who speak Cantonese or Putonghua;
• Mild-to-moderate peripheral hearing loss diagnosed by a pure-tone average of 20-50 dB across octave frequencies of 0.5-4kHz in both ears;
• Not using hearing aids;
• Sensorineural hearing loss (defined as an air-bone gap across 0.5, 1, and 2 kHz<15 dB); and 5) No cognitive impairment \[score of ≦2 on the 5-item Abbreviated Memory Inventory for the Chinese (AMIC)\].

Критерии исключения

• Previously took part in a training intervention study;
• Diagnosed with a major neurocognitive disorder;
• A history of symptomatic stroke or other disease of the central nervous system; speech/ language disorders;
• A serious medical or psychiatric illness (e.g., severe depression, schizophrenia, bi-polar disorder) or a visual impairment that would interfere with engaging in web-based training.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07730775 · 23240731

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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