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

N/ANot Yet RecruitingNCT07608640

Chinese PLA General Hospital3,000 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

3,000

Conditions

Age-related Hearing Loss Dementia

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: 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.

Outcomes

Primary Outcomes

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