Auditory-Cognitive Dual-Task Intervention for Older Adults With Hearing Loss
NCT Number: NCT06486285
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Age-related Hearing Loss|Cognitive Decline|Loneliness|Social Isolation
Interventions: BEHAVIORAL: Auditory-cognitive dual-task training (ACDT)
Sponsor: The Hong Kong Polytechnic University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2025-04

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.

Primary Outcome Measures: 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 Outcome Measures: Learning and memory, The Chinese Auditory Verbal Learning Test will be used., 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)., 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., 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, 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, 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, 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, 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, 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), 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, will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)