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

NCT07608640 | Not Yet Recruiting DMC

• 1 other identifier: CFH 2026-1-5071
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Age-related Hearing Loss; Dementia

Keywords

Dementia; Hearing Loss; Disease Burden; Cohort Study; Predictive Model

Outcome Measures

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.

  3 years from baseline enrollment

Study Arms (1)

Community-Dwelling Older Adults Group

Older adults with bilaterally symmetric hearing and no middle ear abnormalities

Other: Not applicable- observational study

Interventions

Not applicable- observational study OTHER

Not applicable-observational study

Community-Dwelling Older Adults Group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Beijing Youyi Hospital: collaborator
• Peking University People's Hospital: collaborator
• Xuanwu Hospital, Beijing: collaborator

Study Sites (1)

The 6th Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100048, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Presbycusis; Dementia; Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Loss, Sensorineural; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Shiming Yang

  The Medical Ethics Committee of the 6th Medical Center of Chinese PLA General Hospital

  STUDY CHAIR

Central Study Contacts

Lumeng Han

CONTACT

+8666876060; 1345140372@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Physician

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 27, 2026

Record last verified: 2026-05

Locations

CN (1)