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

NCT06486285 | Completed DMC

• 1 other identifier: P0045159
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)

Secondary Outcomes (10)

• Learning and memory

  will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)

• Hearing

  will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)

• Social isolation

  will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)

• Loneliness

  will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)

• Hearing

  will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)

Study Arms (2)

Auditory-cognitive dual-task training (ACDT)

EXPERIMENTAL

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)

Control

NO INTERVENTION

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.

Interventions

Auditory-cognitive dual-task training (ACDT) 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.

Auditory-cognitive dual-task training (ACDT)

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

PolyU

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Presbycusis; Cognitive Dysfunction; Social Isolation

Condition Hierarchy (Ancestors)

Hearing Loss, Sensorineural; Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Social Behavior; Behavior

Study Officials

• Ivy Zhao, Dr

  School of Nursing, the Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: July 3, 2024
• Study Start: August 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: July 1, 2025
• Last Updated: July 18, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

HK (1)