ClinicalTrials.gg
Not yet recruitingNCT07608640AHEADUpdated May 27, 2026

Management of Age-Related Auditory Decline and Early Warning of Its Co-occurring Dementia

An observational study in Age-related Hearing Loss and Dementia, sponsored by Chinese PLA General Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-27.

Sponsored by Chinese PLA General Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Ages
18 Years and older
Sex
All
01

Study summary

Against the backdrop of global population aging, age-related hearing loss (ARHL) has reached epidemic proportions and is increasingly recognized as an independent risk factor for cognitive decline and other major neurodegenerative diseases. This study aims to systematically develop an integrated framework for the early warning, precise assessment, and intervention management of ARHL.

Using a national multicenter design, the project will establish a prospective cohort of more than 3,000 older adults. We will integrate multimodal data including audiological tests, cognitive function assessments, and blood biomarkers, and employ artificial intelligence and unsupervised machine learning methods to address critical bottlenecks in the field: the unclear mechanistic link between ARHL and cognitive decline, and the lack of validated predictive tools.

Specifically, this study will: (1) develop data-driven clinical classification criteria for ARHL; (2) create a personalized "Hearing Health Clock" predictive model; (3) identify minimally invasive blood biomarkers for early detection of cognitive impairment; and (4) formulate a multidimensional early dementia screening program suitable for community-wide implementation. The findings will provide scientific evidence and practical tools for the prevention and control of hearing and cognitive health risks in older adults in China.

02

Conditions studied

  • Age-related Hearing Loss
  • Dementia

Keywords

  • Dementia
  • Hearing Loss
  • Disease Burden
  • Cohort Study
  • Predictive Model
03

In context

Presbycusis

66 studies on the registry are indexed under Presbycusis; 21 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 123 across 20 observational studies indexed under Presbycusis.

Browse Presbycusis studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 570 studies on the registry; 207 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

This study enrolls community-dwelling adults aged 60 years and older from multiple medical centers in China. All participants are permanent local residents with annual residence of no less than 9 months, clear consciousness, and able to cooperate with standardized audiological examinations, cognitive function assessments, questionnaire surveys and blood sample collection.

A total of more than 3,000 older adults will be recruited for the cross-sectional baseline survey. Among them, a sub-cohort of no fewer than 150 older adults with sensorineural hearing loss, bilaterally symmetric auditory thresholds without middle ear disorders, and no non-age-related causes of hearing impairment will be included for 3-year annual longitudinal follow-up.

Individuals with inability to complete pure-tone audiometry, established neurological diseases, severe organ dysfunction, advanced malignant tumor with short life expectancy, or any other inappropriate conditions assessed by investigators are exclud

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.
  2. Clear consciousness and able to cooperate with all study assessments and examinations.
  3. Permanent local residents who have lived in the area for at least 9 months per year and are willing to complete long-term follow-up.

long-term follow-up:

  1. Diagnosis of sensorineural hearing loss.
  2. Bilaterally symmetric hearing with air conduction threshold difference ≤15 dB at 0.5 kHz, 1 kHz, 2 kHz and 4 kHz between two ears.
  3. Hearing loss not caused by non-age-related factors.

Exclusion criteria

Exclusion Criteria:

  1. Unable to complete pure-tone audiometry and other auditory examinations. History of central nervous system diseases, including Parkinson's disease, stroke, intracranial tumor or brain trauma.
  2. Severe uncontrolled systemic diseases (cardiac, pulmonary, hepatic, renal insufficiency) or advanced malignant tumor with expected survival less than 3 years.
  3. Any other condition judged by the investigator inappropriate for study enrollment.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Community-Dwelling Older Adults Group

    Older adults with bilaterally symmetric hearing and no middle ear abnormalities

    Other: Not applicable- observational study

Interventions

  • OtherNot applicable- observational study

    Not applicable-observational study

06

What researchers measure

Primary outcomes

  1. Incidence of dementia and cognitive decline, and progression of age-related auditory decline in community-dwelling older adults

    To determine the 3-year cumulative incidence of all-cause dementia and cognitive decline, and to assess the progression rate of age-related auditory decline among community-dwelling older adults aged 60 years and above. Based on a multicenter prospective cohort of more than 3000 participants, this primary outcome will clarify the longitudinal association between the deterioration of auditory function and subsequent cognitive impairment and dementia risk, through standardized audiological testing and repeated cognitive function assessment at regular follow-up visits.

    Time frame: 3 years from baseline enrollment

07

Study locations

1 site
  • The 6th Medical Center of Chinese PLA General Hospital
    Beijing, Beijing Municipality 100048, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07608640
Responsible party
Shiming Yang, PhD (Professor, Chief Physician, Chinese PLA General Hospital) — Principal investigator
First posted
May 27, 2026
Start date
May 25, 2026 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
May 27, 2026

Study contacts

Lumeng Han
Contact
1345140372@qq.com
+8666876060
Shiming Yang
study chair · The Medical Ethics Committee of the 6th Medical Center of Chinese PLA General Hospital

Oversight

Data monitoring committee
Yes
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 May 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion