Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07608640

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The 6th Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100048, China

Location contact

Lumeng Han

CONTACT

[email protected]

+8666876060

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Not applicable- observational study

Other

Not applicable-observational study

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lumeng Han

CONTACT

[email protected]

+8666876060

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

  • Beijing Youyi Hospital
  • Peking University People's Hospital
  • Xuanwu Hospital, Beijing

Registry information

Acronym: AHEAD

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 27, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.