Management of Age-Related Auditory Decline and Early Warning of Its Co-occurring Dementia (AHEAD)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Lumeng Han
- Numéro de téléphone: +8666876060
- E-mail: 1345140372@qq.com
Lieux d'étude
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Chine, 100048
- The 6th Medical Center of Chinese PLA General Hospital
-
Contact:
- Lumeng Han
- Numéro de téléphone: +8666876060
- E-mail: 1345140372@qq.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
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
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Community-Dwelling Older Adults Group
Older adults with bilaterally symmetric hearing and no middle ear abnormalities
|
Not applicable-observational study
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of dementia and cognitive decline, and progression of age-related auditory decline in community-dwelling older adults
Délai: 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.
|
3 years from baseline enrollment
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Shiming Yang, The Medical Ethics Committee of the 6th Medical Center of Chinese PLA General Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Manifestations neurologiques
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Les troubles mentaux
- Troubles neurocognitifs
- Maladies oto-rhino-laryngologiques
- Troubles des sensations
- Maladies de l'oreille
- Troubles auditifs
- Perte auditive, neurosensorielle
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Démence
- Perte d'audition
- Presbyacousie
Autres numéros d'identification d'étude
- CFH 2026-1-5071 (Autre subvention/numéro de financement: Capital's Funds for Health Improvement and Research)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .