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Completed

NCT Number: NCT06486285

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

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.

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Key information

Conditions

Age-related Hearing Loss Behavior Cognition Disorders Cognitive Decline Cognitive Dysfunction Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Loneliness Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Presbycusis Sensation Disorders Signs and Symptoms Social Behavior Social Isolation

Age range

60 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PolyU

Hong Kong

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Global cognition

    Time frame: will 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 outcomes

  1. Learning and memory

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

    The Chinese Auditory Verbal Learning Test will be used.

  2. Hearing

    Time frame: will 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).

  3. Social isolation

    Time frame: will 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.

  4. Loneliness

    Time frame: will 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

  5. Hearing

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

    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

  6. Attention or working memory

    Time frame: will 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

  7. Information processing speed

    Time frame: will 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

  8. Executive function

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

    Will be assessed by the Chinese Trail Making Test Part B

  9. Verbal fluency

    Time frame: will 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)

  10. Motor skills

    Time frame: will 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

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2024
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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