An interventional study of Auditory-cognitive dual-task training (ACDT) in Age-related Hearing Loss, Cognitive Decline and Loneliness, sponsored by The Hong Kong Polytechnic University. Completed at 1 site in Hong Kong. Open to participants aged 60 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-18.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Prevention
Background: Age-related hearing loss (ARHL) is a common and irreversible condition that has been recently associated with cognitive decline and dementia. Hence, if ARHL is treated earlier, the risk of dementia might decrease. However, in China, only 0.8% of older adults with hearing loss wore hearing aids, and over two-thirds (67.5%) of older adults with ARHL in Hong Kong had either been formally diagnosed or treated. There is also limited information on the feasibility and efficacy of hearing loss interventions for older people in Hong Kong. It is important to develop hearing loss interventions that have the potential to improve cognitive functions among older people.
Aims: This study aims to assess the feasibility and acceptability of a new auditory-cognitive dual-task intervention (ACDT) for community-dwelling older adults with hearing loss, and to examine the preliminary efficacy of ACDT on their cognitive function.
Study design and Methods: This is mixed-model design, using a 2-arm, parallel-group, single-blinded, pilot randomized controlled trial (pilot RCT). A total of 60 community-dwelling older adults in Hong Kong who have mild to moderate hearing loss and normal cognitive performance will be recruited. Participants will be randomly assigned to the auditory-cognitive dual-task intervention group (ACDTG), and control group with no specific intervention (a "wait list" group) (CG). Each ACDTG participant will receive the intervention for 12 weeks (5 days x 60-min sessions per day). All participants in all groups will be assessed for cognitive function (primary outcome), social isolation, and loneliness, and hearing at baseline (T0), and after the intervention (T1). Post-intervention interviews will be conducted to obtain perspectives of participants in the ACDTG on the feasibility and acceptability of the ACDT intervention.
Data analysis: Participant characteristics and outcome variables will be analysed through descriptive statistics. Differences in cognition score and other outcomes across time points among the participant groups will be measured by Generalized Estimating Equations (GEE). The statistical software package IBM SPSS version 26.0 will be used. Content analysis will used to analyse the post-intervention interviews.
Expected results: ACDT will be feasible for implementation and acceptable for community-dwelling older adults with hearing loss. While ACDT will not be able to improve underlying hearing in ARHL, it will be more effective on improving participants' cognitive function, social engagement and loneliness, and ability in information processing, interpretation and communication, than CG.
66 studies on the registry are indexed under Presbycusis; 21 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 45 interventional studies indexed under Presbycusis.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The new auditory-cognitive dual-task training (ACDT) is a 12-week program (5 times/week, 60 minutes per day). Auditory training (i.e., speech-in-noise training, rapid speech training and competing speaking training) will be incorporated with cognitive exercises involving the domains of executive function, perceptual-motor ability, memory, and complex attention.
Behavioral: Auditory-cognitive dual-task training (ACDT)
no specific treatment. This is a "wait list" group, participants can choose either the Auditory-cognitive dual-task training or the cognitive training after 12 weeks.
The components of auditory training are designed based on an auditory training and aural rehabilitation program LACETM (Listening \& Communication Enhancement) developed by our study team member. The cognitive training was developed and tested feasible and valid in our study team's previous dual-task Zumba cognitive training.
Global cognition
Global cognition will be measured by the Hong Kong-Montreal Cognitive Assessment (HK-MoCA). MoCA measures multiple cognitive domains, including attention, orientation, concentration, language, memory, executive functions and visuo-spatial skills. MoCA ≥26 is considered as normal, while 22-26 refers to mild cognitive impairment.
Time frame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
Learning and memory
The Chinese Auditory Verbal Learning Test will be used.
Time frame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
Hearing
will be measured by an audiometer with sound level meter (to measure ambient noise).
Time frame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
Social isolation
will be measured by validated abbreviated 6-item Chinese version of the Lubben Social Network Scale (LSNS), which was developed specifically for use among older adults and shown to be both reliable and valid.The total score is calculated by finding the sum of the all items. For the LSNS-R, the score ranges between 0 and 60, with a higher score indicating more social engagement. For the LSNS-6, the score ranges between 0 and 30, with a higher score indicating more social engagement.
Time frame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
Loneliness
will be measured by the 6-item De Jong Gierveld loneliness scale (Chinese version). The total score of the scale ranges from zero to six, with higher scores indicating greater feelings of loneliness. A cut-off score of two or more was used to indicate the presence of loneliness, as recommended by van Tilburg and De Jong Gierveld
Time frame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
Hearing
Chinese version of the Hearing Handicap Inventory for the Elderly and the five-point Communication Scale for Older Adults will be utilized. The questionnaire consists of 10 items-five social/situational items and five emotional response items-with a total score range of 0-40. A "YES" response receives four points, a "NO" response receives zero points, and a "SOMETIMES" response receives two points. The HHIE-S total scores were used to classify the results into three categories: 0 to 8 (no self-perceived hearing handicap), 10-24 (mild to moderate handicap), and 26-40 (severe handicap). According to the American Speech-Language-Hearing Association's proposed recommendations, a total HHIE-S score of 8 indicates the presence of a hearing handicap
Time frame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
Attention or working memory
will be measured by the digit span (forward and backward) and visual span (forward and backward) methods
Time frame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
Information processing speed
will be assessed by the performance on the Chinese Trail Making Test Part A
Time frame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
Executive function
Will be assessed by the Chinese Trail Making Test Part B
Time frame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
Verbal fluency
will be assessed by the category verbal fluency tests (animal, fruit, and vegetable)
Time frame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
Motor skills
will be evaluated by the grooved pegboard for both dominant hand and nondominant hand
Time frame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
Plan to share: Yes — Individual deidentified participant data (including data dictionaries) will be shared. The investigators will publish research findings in peer reviewed and international official journals without Individual identifiable participant information according to the ethical requirement. Individual deidentified participant dataset can be shared per request and approved by the research core team.
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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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