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

NCT ID: NCT06486285

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-07-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Auditory-cognitive dual-task training (ACDT)

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.

Group Type: EXPERIMENTAL

Auditory-cognitive dual-task training (ACDT)

Intervention Type: BEHAVIORAL

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.

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Auditory-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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ivy Zhao, Dr

Role: PRINCIPAL_INVESTIGATOR

School of Nursing, the Hong Kong Polytechnic University

Locations

PolyU

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

P0045159

Identifier Type: -

Identifier Source: org_study_id