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Not yet recruitingNCT07612618Updated May 29, 2026

Prediction of Age-Related Hearing Loss Based on Comprehensive Risk Factors

An observational study in Age-related Hearing Loss, sponsored by Chinese PLA General Hospital. Not yet recruiting. Open to participants aged 60 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-29.

Sponsored by Chinese PLA General Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
60 Years to 100 Years
Sex
All
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Study summary

This study aims to develop a predictive model for age-related hearing loss (ARHL) based on multi-source risk factors and artificial intelligence techniques. A retrospective analysis will be conducted on 1,000 cases with 15-year longitudinal clinical data, including audiological assessments and noise exposure history. Machine learning algorithms will be employed to construct a predictive model for hearing loss progression. Additionally, a prospective cohort of 100 community-dwelling elderly individuals will be enrolled. Blood samples will be collected for low-abundance targeted proteomics analysis to screen for biomarkers associated with cognitive impairment. This study will establish an early risk identification tool for ARHL and propose strategies for the screening and prevention of dementia in individuals with hearing impairment, thereby providing evidence-based support for early intervention in auditory and cognitive health in the elderly.

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Conditions studied

  • Age-related Hearing Loss

Keywords

  • Age-related hearing loss
  • prediction model
  • machine learning
  • proteomics
  • cognitive impairment
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In context

Presbycusis

66 studies on the registry are indexed under Presbycusis; 21 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 123 across 20 observational studies indexed under Presbycusis.

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Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 570 studies on the registry; 207 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

This study enrolls community-dwelling adults aged ≥60 years from multiple Chinese centers. Inclusion: occupational noise exposure, longitudinal pure-tone audiometry, complete clinical data. Exclusion: non-age/noise hearing loss (e.g., otitis media, otosclerosis, Meniere's disease), missing data >20%, severe mental/cognitive impairment.

The prospective cohort (n=100) recruited from community health centers in North and East China. Inclusion: permanent local residents (≥9 months/year), able to complete assessments, WHO ARHL criteria (PTA≥25 dB HL), written consent. Exclusion: severe psychiatric disorders, major organ failure (NYHA III-IV, eGFR\<30), life expectancy \<3 years, non-ARHL loss, diagnosed dementia, Parkinson's, stroke with severe sequelae, or other unsuitable conditions.

Prospective participants followed at baseline, 12 months. Among them, 50 ARHL with cognitive impairment (MoCA\<26) and 50 with ARHL+normal cognition (MoCA≥26) receive proteomics analysis for biomarker discovery

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥ 60 years;
  2. Availability of longitudinal pure-tone audiometry data;
  3. Documented history of occupational noise exposure;
  4. Complete clinical data (including past medical history and medication history).

Exclusion criteria

Exclusion Criteria:

  1. Hearing loss caused by non-age or non-noise factors (e.g., otitis media, otosclerosis, Meniere's disease);
  2. Missing clinical data >20%;
  3. Concurrent severe mental illness or cognitive impairment (unable to complete audiological assessment).
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Community-Dwelling Older Adults Group

    Older adults with bilaterally symmetric hearing and no middle ear abnormalities

    Other: Not applicable- observational study

Interventions

  • OtherNot applicable- observational study

    Not applicable-observational study

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What researchers measure

Primary outcomes

  1. AUC of ARHL machine learning model and cognitive-related protein biomarkers

    To evaluate the discriminative performance (area under the receiver operating characteristic curve, AUC) of a machine learning-based predictive model for age-related hearing loss (ARHL) integrating multidimensional risk factors, and to identify serum protein biomarkers associated with cognitive impairment in ARHL patients. Based on a retrospective training cohort of 1,000 participants with 15-year longitudinal data and a prospective external validation cohort of 100 community-dwelling older adults aged 60 years and above, this primary outcome will assess the predictive accuracy (target AUC ≥0.8) of the optimal model (e.g., random forest, XGBoost, or neural network) using standardized pure-tone audiometry, and will determine the diagnostic performance (target AUC ≥0.75) of candidate protein biomarkers for cognitive decline (MoCA \<26) through low-abundance targeted proteomics (pSILAC-HPLC-MS/MS). Repeated cognitive assessments (MoCA, MMSE, CDR) at baseline, 12 months will

    Time frame: Baseline and 12 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07612618
Responsible party
Shiming Yang, PhD (Professor, Chief Physician, Chinese PLA General Hospital) — Principal investigator
First posted
May 29, 2026
Start date
Jun 1, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
May 29, 2026

Study contacts

Denghao Zheng
Contact
Zhengdh2648@163.com
+8666876060

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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