Age-related Hearing LossAHEADNCT07608640
Management of Age-Related Auditory Decline and Early Warning of Its Co-occurring Dementia
An observational study of Age-related Hearing Loss and Dementia, run by Chinese PLA General Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-related Hearing Loss, Dementia
- What is being tested?
- Not applicable- observational study
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2026to 31 Dec 2028
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Aged 60 years or older.
- Clear consciousness and able to cooperate with all study assessments and examinations.
- 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：
- Diagnosis of sensorineural hearing loss.
- Bilaterally symmetric hearing with air conduction threshold difference ≤15 dB at 0.5 kHz, 1 kHz, 2 kHz and 4 kHz between two ears.
- Hearing loss not caused by non-age-related factors.
Who cannot join
- 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.
- Severe uncontrolled systemic diseases (cardiac, pulmonary, hepatic, renal insufficiency) or advanced malignant tumor with expected survival less than 3 years.
- Any other condition judged by the investigator inappropriate for study enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The 6th Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100048
Lumeng Han, +8666876060, 1345140372@qq.com
About this study
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.
- Conditions
- Age-related Hearing Loss, Dementia
- Being tested
- Not applicable- observational study
- Keywords
- Dementia, Hearing Loss, Disease Burden, Cohort Study, Predictive Model
- Medical subject headings
- Presbycusis, Dementia, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
Not applicable-observational study
| Study group | Role | What they receive |
|---|---|---|
| Community-Dwelling Older Adults Group | Older adults with bilaterally symmetric hearing and no middle ear abnormalities Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years from baseline enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start25 May 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
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.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Youyi Hospital, Peking University People's Hospital, Xuanwu Hospital, Beijing
- Responsible party
- Principal investigator, Shiming Yang, PhD, Chinese PLA General Hospital
- Investigators
- Shiming Yang, Study chair, The Medical Ethics Committee of the 6th Medical Center of Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608640
- Sponsor's protocol ID
- CFH 2026-1-5071
- Other IDs
- CFH 2026-1-5071
- Acronym
- AHEAD
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Age-Related Auditory Decline and Early Warning of Its Co-occurring Dementia
- ClinicalTrials.gov ID
- NCT07608640
- Acronym / sponsor ID
- AHEAD / CFH 2026-1-5071
- Conditions
- Age-related Hearing Loss, Dementia
- Keywords
- Dementia, Hearing Loss, Disease Burden, Cohort Study, Predictive Model
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Beijing Youyi Hospital, Peking University People's Hospital, Xuanwu Hospital, Beijing
- Study start
- 25 May 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 May 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Community-Dwelling Older Adults Group | – | Other: Not applicable- observational studyOlder adults with bilaterally symmetric hearing and no middle ear abnormalities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- Aged 60 years or older.
- Clear consciousness and able to cooperate with all study assessments and examinations.
- 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：
- Diagnosis of sensorineural hearing loss.
Key exclusion criteria (3 listed)
- 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.
- Severe uncontrolled systemic diseases (cardiac, pulmonary, hepatic, renal insufficiency) or advanced malignant tumor with expected survival less than 3 years.
- Any other condition judged by the investigator inappropriate for study enrollment.
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 |
|---|---|---|
| Not applicable- observational studyNot applicable-observational study | Other | Community-Dwelling Older Adults Group |
Primary outcome
Incidence of dementia and cognitive decline, and progression of age-related auditory decline in community-dwelling older adults
Time frame: 3 years from baseline enrollment
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.
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 27 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Shiming Yang study chair
The Medical Ethics Committee of the 6th Medical Center of Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-related Hearing Loss and Dementia, run by Chinese PLA General Hospital at 1 site in China.
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 7 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 27 May 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 China. 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 Lumeng Han (+8666876060, 1345140372@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dementia and cognitive decline, and progression of age-related auditory decline in community-dwelling older adults (time frame: 3 years from baseline enrollment). 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 27 May 2026.