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Not yet recruiting NCT07730775

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

No phase Interventional Auditory-cognitive Dual-task Training

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Web-based gamified auditory-cognitive sequential dual-task training system, Control.
Who it may be relevant to
Registry conditions: Auditory-cognitive Dual-task Training. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral 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
  • Behavioral 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.

Primary outcome measures

  • Hearing Handicap Inventory for the Elderly [Time frame: at week 6, immediately post-intervention (week 12), and week 24]
Secondary outcome measures (4)
  • The Cantonese Hearing in Noise Test [Time frame: at week 6, immediately post-intervention (week 12), and week 24]
  • The Chinese Auditory Verbal Learning Test [Time frame: at week 6, immediately post-intervention (week 12), and week 24]
  • The Chinese Trial Making Test Part A& B [Time frame: at week 6, immediately post-intervention (week 12), and week 24]
  • Dual task of listening and working memory [Time frame: at week 6, immediately post-intervention (week 12), and week 24]

Eligibility criteria

Inclusion criteria

  • 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 \[score of ≦2 on the 5-item Abbreviated Memory Inventory for the Chinese (AMIC)\].

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07730775 · 23240731

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗