Clinical trial NCT06486285: Auditory-Cognitive Dual-Task Intervention for Older Adults With Hearing Loss
Official title: Auditory-Cognitive Dual-Task Intervention for Older Adults With Hearing Loss: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Age-related Hearing Loss
Cognitive Decline
Loneliness
Social Isolation
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Global cognition
timeFrame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
Secondary outcomes:
measure: Learning and memory
timeFrame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
measure: Hearing
timeFrame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
measure: Social isolation
timeFrame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
measure: Loneliness
timeFrame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
measure: Hearing
timeFrame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
measure: Attention or working memory
timeFrame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
measure: Information processing speed
timeFrame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
measure: Executive function
timeFrame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
measure: Verbal fluency
timeFrame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
measure: Motor skills
timeFrame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
Other outcomes:
Locations:
Study officials:
affiliation: School of Nursing, the Hong Kong Polytechnic University
name: Ivy Zhao, Dr
role: PRINCIPAL_INVESTIGATOR
References: