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Auditory-Cognitive Dual-Task Intervention for Older Adults With Hearing Loss

Auditory-Cognitive Dual-Task Intervention for Older Adults With Hearing Loss: A Pilot Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06486285
Enrollment
60
Registered
2024-07-03
Start date
2024-08-01
Completion date
2025-07-01
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related Hearing Loss, Cognitive Decline, Loneliness, Social Isolation

Brief summary

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.

Interventions

BEHAVIORALAuditory-cognitive dual-task training (ACDT)

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.

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

* aged 60 and above living in the community; * have mild to moderate hearing loss with a pure-tone average (PTA) between 25 and 60 dB in both ears (average hearing threshold at 0.5, 1, 2, and 4 kHz measuring by audiometer with headphones in a quite listening environment, no hearing aid use within the past 6 months; * with normal cognitive performance (MoCA score ≥26); and * are willing to and capable of providing informed consent and complying with study procedures.

Exclusion criteria

* have a history of psychosis, mania, bipolar disorder, substance use disorder or have current suicidal ideation; * with severe or unstable medical illness, significant retrocochlear pathology or organic lesion responsible for hearing loss; * a diagnosis of probable Alzheimer's disease, vascular dementia, FTD, or Parkinson's Disease; and * taking medications such as antidepressants, sedatives, or antiepileptics that may affect cognition.

Design outcomes

Primary

MeasureTime frameDescription
Global cognitionwill be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)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.

Secondary

MeasureTime frameDescription
Hearingwill be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)will be measured by an audiometer with sound level meter (to measure ambient noise).
Social isolationwill be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)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.
Lonelinesswill be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)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
Attention or working memorywill be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)will be measured by the digit span (forward and backward) and visual span (forward and backward) methods
Learning and memorywill be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)The Chinese Auditory Verbal Learning Test will be used.
Executive functionwill be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)Will be assessed by the Chinese Trail Making Test Part B
Verbal fluencywill be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)will be assessed by the category verbal fluency tests (animal, fruit, and vegetable)
Motor skillswill be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)will be evaluated by the grooved pegboard for both dominant hand and nondominant hand
Information processing speedwill be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)will be assessed by the performance on the Chinese Trail Making Test Part A

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026