Age-related Hearing LossNCT06486285
Auditory-Cognitive Dual-Task Intervention for Older Adults With Hearing Loss
A study testing Auditory-cognitive dual-task training (ACDT) in people with Age-related Hearing Loss and Cognitive Decline, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-related Hearing Loss, Cognitive Decline, Loneliness
- What is being tested?
- Auditory-cognitive dual-task training (ACDT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Auditory-Cognitive Dual-Task Intervention for Older Adults With Hearing Loss: A Pilot Randomized Controlled Trial
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.
Read more
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.
- Being tested
- Auditory-cognitive dual-task training (ACDT)
- Medical subject headings
- Presbycusis, Cognitive Dysfunction, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory-cognitive dual-task training (ACDT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
Secondary outcomes (10)
Learning and memory
The Chinese Auditory Verbal Learning Test will be used.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Aug 2024
- Primary completion30 Jun 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ivy Zhao, Dr, Principal investigator, School of Nursing, the Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486285
- Sponsor's protocol ID
- P0045159
- Status last verified
- Jun 2024
- First submitted
- 18 Jun 2024
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual deidentified participant data (including data dictionaries) will be shared. The investigators will publish research findings in peer reviewed and international official journals without Individual identifiable participant information according to the ethical requirement. Individual deidentified participant dataset can be shared per request and approved by the research core team.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auditory-Cognitive Dual-Task Intervention for Older Adults With Hearing Loss: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06486285
- Acronym / sponsor ID
- P0045159
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auditory-cognitive dual-task training (ACDT) | Experimental | Behavioral: 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. |
| 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. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Auditory-cognitive dual-task training (ACDT) |
Primary outcome
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.
10 secondary outcomes
Learning and memory
Time frame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
Hearing
Time frame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
Social isolation
Time frame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
Loneliness
Time frame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
Hearing
Time frame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
Attention or working memory
Time frame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
Information processing speed
Time frame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
Executive function
Time frame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
Verbal fluency
Time frame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
Motor skills
Time frame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: Yes. Individual deidentified participant data (including data dictionaries) will be shared. The investigators will publish research findings in peer reviewed and international official journals without Individual identifiable participant information according to the ethical requirement. Individual deidentified participant dataset can be shared per request and approved by the research core team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivy Zhao, Dr principal investigator
School of Nursing, the Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory-cognitive dual-task training (ACDT) in people with Age-related Hearing Loss and Cognitive Decline, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global cognition (time frame: will be assessed at baseline (T0), and Week 12 (immediately after the intervention) (T1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025; AzTrials last refreshed its copy on 31 Oct 2026.