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Not yet recruitingNCT07869745A-COPUpdated Oct 13, 2026

Auditory-Cognitive Optimization Care Program for Older Adults With Hearing Loss and Cognitive Impairment

An interventional study of Auditory-Cognitive Optimization Care Program (A-COP) and Hearing Management and Newspaper-Reading Activities in Hearing Loss and Cognitive Impairment, sponsored by Taipei Medical University. Not yet recruiting at 1 site in Taiwan. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Taipei Medical University · Not applicable, Interventional, and Supportive care

Updated Oct 13, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Hearing Loss
  • Cognitive Impairment
03

In context

Hearing Loss

1,109 studies on the registry are indexed under Hearing Loss; 233 are open to participants now.

This study's planned enrollment of 76 is above the median of 40 across 778 interventional studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

Taipei Medical University is the lead sponsor of 256 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Aged 60 years or older and able to communicate in Mandarin Chinese or Taiwanese.
  2. Self-reported hearing and cognitive decline and able to complete hearing, communication, and cognitive assessments.
  3. HHIE-S score ≥9, followed by pure-tone audiometry, and HI-MoCA score of 18-24.
  4. 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.
  5. Willing to participate voluntarily and provide written informed consent after receiving an explanation of the study purpose, procedures, potential risks, and participant rights.

Exclusion criteria

Exclusion Criteria:

  1. Received structured cognitive stimulation, cognitive training, cognitive rehabilitation, or related care or treatment within the previous 6 months.
  2. Severe psychiatric illness, significant behavioral problems, or other conditions judged by a physician to interfere with participation in the study procedures or intervention activities.
  3. Severe visual, hearing, or communication impairment that prevents understanding of the study information or completion of the assessment measures.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
76 participants (estimated)

Study arms

  • Experimental
    A-COP Intervention Group

    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.

    Behavioral: Auditory-Cognitive Optimization Care Program (A-COP)

  • Active comparator
    Active Control Group

    Participants will receive hearing management and newspaper-reading activities as an active control intervention.

    Behavioral: Hearing Management and Newspaper-Reading Activities

Interventions

  • BehavioralAuditory-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.

  • BehavioralHearing Management and Newspaper-Reading Activities

    An active control intervention consisting of hearing management and newspaper-reading activities.

06

What researchers measure

Primary outcomes

  1. Global Cognitive Function

    Assessed using the Hearing-Impaired Montreal Cognitive Assessment (HI-MoCA).

    Time frame: Baseline, immediately post-intervention, 3-month follow-up, and 6-month follow-up

  2. Executive Function

    Assessed using the Trail Making Test Parts A and B (TMT-A and TMT-B).

    Time frame: Baseline, immediately post-intervention, 3-month follow-up, and 6-month follow-up

  3. Working Memory

    Assessed using the Digit Span Test (DST).

    Time frame: Baseline, immediately post-intervention, 3-month follow-up, and 6-month follow-up

Secondary outcomes

  1. Hearing Threshold

    Assessed using pure-tone audiometry (PTA).

    Time frame: Baseline, immediately post-intervention, 3-month follow-up, and 6-month follow-up

  2. Speech-in-Noise Performance

    Assessed using the Taiwan Mandarin Hearing in Noise Test (TMHINT).

    Time frame: Baseline, immediately post-intervention, 3-month follow-up, and 6-month follow-up

  3. Communication Ability

    Assessed using the Hearing Handicap Inventory for the Elderly-Screening Version (HHIE-S).

    Time frame: Baseline, immediately post-intervention, 3-month follow-up, and 6-month follow-up

  4. Depressive Symptoms

    Assessed using the Geriatric Depression Scale (GDS).

    Time frame: Baseline, immediately post-intervention, 3-month follow-up, and 6-month follow-up

  5. Health-Related Quality of Life

    Assessed using the 12-Item Short Form Health Survey (SF-12).

    Time frame: Baseline, immediately post-intervention, 3-month follow-up, and 6-month follow-up

Other outcomes

  1. Hearing Aid Benefit

    Assessed using the International Outcome Inventory for Hearing Aids (IOI-HA) among hearing aid users.

    Time frame: Baseline, immediately post-intervention, 3-month follow-up, and 6-month follow-up

07

Study locations

1 site
  • Taipei Medical University Hospital
    Taipei, Taipei City 110, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2027; primary completion for Dec 2030, 46 months later.

Of 268 non-industry interventional studies with no phase under Hearing Loss, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 61. This study's planned 46 months is above that.

Counting every sponsor, half of 444 studies reached it within 17 months; a quarter within 5 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 4, 2026
First posted
Oct 13, 2026
StartEst.
Feb 2027
Primary completionEst.
Dec 2030
CompletionEst.
Dec 2030
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07869745
Responsible party
Sponsor
First posted
Oct 13, 2026
Start date
Feb 2027 (estimated)
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Oct 13, 2026

Study contacts

Jia-You Ye, Ph.D
Contact
d432109005@tmu.edu.tw
+88627372181 ext. 27764

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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