Hearing LossA-COPNCT07869745
Auditory-Cognitive Optimization Care Program for Older Adults With Hearing Loss and Cognitive Impairment
A study testing Auditory-Cognitive Optimization Care Program (A-COP) and Hearing Management and Newspaper-Reading Activities in people with Hearing Loss and Cognitive Impairment, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Hearing loss and cognitive impairment are common and interrelated health problems that may affect communication, information processing, attention, psychological well-being, daily functioning, and quality of life. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hearing Loss, Cognitive Impairment
- What is being tested?
- Auditory-Cognitive Optimization Care Program (A-COP) and Hearing Management and Newspaper-Reading Activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2027to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 60 years or older and able to communicate in Mandarin Chinese or Taiwanese.
- Self-reported hearing and cognitive decline and able to complete hearing, communication, and cognitive assessments.
- HHIE-S score ≥9, followed by pure-tone audiometry, and HI-MoCA score of 18-24.
- Hearing loss confirmed by an otolaryngologist, defined as a pure-tone average at 0.5, 1, 2, and 4 kHz of ≥21 dB HL in the better-hearing ear.
- Willing to participate voluntarily and provide written informed consent after receiving an explanation of the study purpose, procedures, potential risks, and participant rights.
Who cannot join
- Received structured cognitive stimulation, cognitive training, cognitive rehabilitation, or related care or treatment within the previous 6 months.
- Severe psychiatric illness, significant behavioral problems, or other conditions judged by a physician to interfere with participation in the study procedures or intervention activities.
- Severe visual, hearing, or communication impairment that prevents understanding of the study information or completion of the assessment measures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Taipei Medical University Hospital
Taipei, Taipei City, 110
Jia-You Ye, Ph.D, +88627372181 ext. 27764, d432109005@tmu.edu.tw
About this study
Official title: Development and Evaluation of a Comorbidity-Oriented Auditory-Cognitive Optimization Care Program (A-COP) for Individuals With Hearing Loss and Cognitive Impairment: A Longitudinal, Single-Blind, Two-Arm, Parallel-Group Randomized Controlled Trial
Hearing loss and cognitive impairment are common and interrelated health problems that may affect communication, information processing, attention, psychological well-being, daily functioning, and quality of life. This study aims to develop and evaluate a comorbidity-oriented Auditory-Cognitive Optimization Care Program (A-COP) for individuals with hearing loss and cognitive impairment.
The A-COP will be developed based on evidence from a literature review and findings from qualitative research involving individuals with hearing loss and cognitive impairment and their caregivers. The program integrates hearing-related care and cognitive stimulation strategies to address the combined needs associated with hearing and cognitive difficulties.
In the intervention phase, participants will be randomly assigned to either the A-COP intervention group or an active control group in a two-arm, parallel-group randomized controlled trial. The study will evaluate changes in cognitive function, hearing and communication-related outcomes, depressive symptoms, and quality of life from baseline through the 6-month follow-up. The findings will provide evidence regarding the effects of the A-COP in individuals with hearing loss and cognitive impairment.
- Conditions
- Hearing Loss, Cognitive Impairment
- Being tested
- Auditory-Cognitive Optimization Care Program (A-COP), Hearing Management and Newspaper-Reading Activities
- Medical subject headings
- Hearing Loss, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory-Cognitive Optimization Care Program (A-COP)Behavioural
A structured, group-based care program integrating hearing management, cognitive stimulation training, and communication practice to support auditory, cognitive, and communication functioning.
Hearing Management and Newspaper-Reading ActivitiesBehavioural
An active control intervention consisting of hearing management and newspaper-reading activities.
| Study group | Role | What they receive |
|---|---|---|
| A-COP Intervention Group | Experimental | Participants will receive the Auditory-Cognitive Optimization Care Program (A-COP), which integrates hearing management, cognitive stimulation training, and communication practice in a small-group format. Receives: Behavioral: Auditory-Cognitive Optimization Care Program (A-COP) |
| Active Control Group | Active comparator | Participants will receive hearing management and newspaper-reading activities as an active control intervention. Receives: Behavioral: Hearing Management and Newspaper-Reading Activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Cognitive Function
Assessed using the Hearing-Impaired Montreal Cognitive Assessment (HI-MoCA).
Measured: Baseline, immediately post-intervention, 3-month follow-up, and 6-month follow-up
Executive Function
Assessed using the Trail Making Test Parts A and B (TMT-A and TMT-B).
Measured: Baseline, immediately post-intervention, 3-month follow-up, and 6-month follow-up
Working Memory
Assessed using the Digit Span Test (DST).
Measured: Baseline, immediately post-intervention, 3-month follow-up, and 6-month follow-up
Secondary outcomes (5)
Hearing Threshold
Assessed using pure-tone audiometry (PTA).
Measured: Baseline, immediately post-intervention, 3-month follow-up, and 6-month follow-up
Speech-in-Noise Performance
Assessed using the Taiwan Mandarin Hearing in Noise Test (TMHINT).
Measured: Baseline, immediately post-intervention, 3-month follow-up, and 6-month follow-up
Communication Ability
Assessed using the Hearing Handicap Inventory for the Elderly-Screening Version (HHIE-S).
Measured: Baseline, immediately post-intervention, 3-month follow-up, and 6-month follow-up
Depressive Symptoms
Assessed using the Geriatric Depression Scale (GDS).
Measured: Baseline, immediately post-intervention, 3-month follow-up, and 6-month follow-up
Health-Related Quality of Life
Assessed using the 12-Item Short Form Health Survey (SF-12).
Measured: Baseline, immediately post-intervention, 3-month follow-up, and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study startFeb 2027 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869745
- Sponsor's protocol ID
- TMU-ACOP-2026-01
- Acronym
- A-COP
- Status last verified
- Sep 2026
- First submitted
- 4 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Comorbidity-Oriented Auditory-Cognitive Optimization Care Program (A-COP) for Individuals With Hearing Loss and Cognitive Impairment: A Longitudinal, Single-Blind, Two-Arm, Parallel-Group Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07869745
- Acronym / sponsor ID
- A-COP / TMU-ACOP-2026-01
- Conditions
- Hearing Loss, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- Feb 2027 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 13 Oct 2026 (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.
Hearing loss and cognitive impairment are common and interrelated health problems that may affect communication, information processing, attention, psychological well-being, daily functioning, and quality of life. This study aims to develop and evaluate a comorbidity-oriented Auditory-Cognitive Optimization Care Program (A-COP) for individuals with hearing loss and cognitive impairment.
The A-COP will be developed based on evidence from a literature review and findings from qualitative research involving individuals with hearing loss and cognitive impairment and their caregivers. The program integrates hearing-related care and cognitive stimulation strategies to address the combined needs associated with hearing and cognitive difficulties.
In the intervention phase, participants will be randomly assigned to either the A-COP intervention group or an active control group in a two-arm, parallel-group randomized controlled trial. The study will evaluate changes in cognitive function, hearing and communication-related outcomes, depressive symptoms, and quality of life from baseline through the 6-month follow-up. The findings will provide evidence regarding the effects of the A-COP in individuals with hearing loss and cognitive impairment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-COP Intervention Group | Experimental | Behavioral: Auditory-Cognitive Optimization Care Program (A-COP)Participants will receive the Auditory-Cognitive Optimization Care Program (A-COP), which integrates hearing management, cognitive stimulation training, and communication practice in a small-group format. |
| Active Control Group | Active comparator | Behavioral: Hearing Management and Newspaper-Reading ActivitiesParticipants will receive hearing management and newspaper-reading activities as an active control intervention. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 60 years or older and able to communicate in Mandarin Chinese or Taiwanese.
- Self-reported hearing and cognitive decline and able to complete hearing, communication, and cognitive assessments.
- HHIE-S score ≥9, followed by pure-tone audiometry, and HI-MoCA score of 18-24.
- Hearing loss confirmed by an otolaryngologist, defined as a pure-tone average at 0.5, 1, 2, and 4 kHz of ≥21 dB HL in the better-hearing ear.
- Willing to participate voluntarily and provide written informed consent after receiving an explanation of the study purpose, procedures, potential risks, and participant rights.
Key exclusion criteria (3 listed)
- Received structured cognitive stimulation, cognitive training, cognitive rehabilitation, or related care or treatment within the previous 6 months.
- Severe psychiatric illness, significant behavioral problems, or other conditions judged by a physician to interfere with participation in the study procedures or intervention activities.
- Severe visual, hearing, or communication impairment that prevents understanding of the study information or completion of the assessment measures.
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 Optimization Care Program (A-COP)A structured, group-based care program integrating hearing management, cognitive stimulation training, and communication practice to support auditory, cognitive, and communication functioning. | Behavioural | A-COP Intervention Group |
| Hearing Management and Newspaper-Reading ActivitiesAn active control intervention consisting of hearing management and newspaper-reading activities. | Behavioural | Active Control Group |
Primary outcome
Global Cognitive Function
Time frame: Baseline, immediately post-intervention, 3-month follow-up, and 6-month follow-up
Assessed using the Hearing-Impaired Montreal Cognitive Assessment (HI-MoCA).
Executive Function
Time frame: Baseline, immediately post-intervention, 3-month follow-up, and 6-month follow-up
Assessed using the Trail Making Test Parts A and B (TMT-A and TMT-B).
Working Memory
Time frame: Baseline, immediately post-intervention, 3-month follow-up, and 6-month follow-up
Assessed using the Digit Span Test (DST).
5 secondary outcomes
Hearing Threshold
Time frame: Baseline, immediately post-intervention, 3-month follow-up, and 6-month follow-up
Speech-in-Noise Performance
Time frame: Baseline, immediately post-intervention, 3-month follow-up, and 6-month follow-up
Communication Ability
Time frame: Baseline, immediately post-intervention, 3-month follow-up, and 6-month follow-up
Depressive Symptoms
Time frame: Baseline, immediately post-intervention, 3-month follow-up, and 6-month follow-up
Health-Related Quality of Life
Time frame: Baseline, immediately post-intervention, 3-month follow-up, and 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Hearing Loss
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitation
Self-monitoring of Hearing Aids Using Artificial Intelligence
Hearing Loss
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
Not yet recruitingPhase 1/2
A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
Cochlear Synaptopathy
Recruiting
Assessing Pharmacy Technician Educational Training for the Provision of Over-the-Counter Hearing Aids in Rural Alabama and Mississippi Pharmacies
Bilateral Hearing Loss, Health Services Research
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.
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 Optimization Care Program (A-COP) and Hearing Management and Newspaper-Reading Activities in people with Hearing Loss and Cognitive Impairment, run by Taipei Medical University at 1 site in Taiwan.
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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 13 Oct 2026. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jia-You Ye, Ph.D (+88627372181 ext. 27764, d432109005@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Cognitive Function (time frame: Baseline, immediately post-intervention, 3-month follow-up, and 6-month follow-up). The study lists 3 primary outcomes in all. 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 13 Oct 2026.