Management of Age-Related Auditory Decline and Early Warning of Its Co-occurring Dementia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese PLA General Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Diagnosis of sensorineural hearing loss.
Disqualifiers
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 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not applicable- observational study
Other interventionNot applicable-observational study
Treatment groups
3,000 Participants
are divided into 1 treatment groupGroup A: Community-Dwelling Older Adults Group1 intervention
Trial outcomes
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 enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Chinese PLA General Hospital
Lead sponsor
Beijing Youyi Hospital
Collaborator
Peking University People's Hospital
Collaborator
Xuanwu Hospital, Beijing
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: