Efficacy and Safety of rTMS Combined With HA in the Treatment of Cognitive Decline in Aged Related Hearing Loss
Recruiting now · Not applicable
Conditions studied: Senile Deadness
In brief
This study is a real-world interventional trial enrolling 189 participants: older adults with age-related hearing loss not using hearing aids (ARHL-nonHA), those using hearing aids (ARHL-HA), and those with normal hearing (HC). All groups will undergo hearing, cognitive (MMSE, MoCA, SCWT, DST, TMT), depression (GDS-15, HAMD-24), sleep (PSQI), and brain imaging (EEG, sMRI, rs-fMRI, task-fMRI) assessments. The ARHL-nonHA and ARHL-HA groups will receive two 14-day courses of high-frequency rTMS (one session daily). One month after treatment, reassessments will be conducted in these two groups. Data will then be analyzed to evaluate the cognitive benefits of rTMS combined with hearing aids and to explore the underlying brain mechanisms.
Key facts
- Study ID
- NCT07389213
- Run by
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- People needed
- 189
- Starts
- 2025-05-01
- Expected to finish
- 2028-08-31
- Last updated by the study team
- 2026-02-05
Who can join
Age: 50 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age ≥50 years and ≤85 years, regardless of gender.
- Diagnosed with age-related hearing loss (ARHL), characterized by symmetrical, slowly progressing hearing loss primarily affecting high frequencies, along with decreased speech recognition ability due to aging. This is in accordance with the "Expert Consensus on Diagnosis and Intervention of Age-Related Hearing Loss" 2019 edition.(Only ARHL-nonHA group and ARHL-HA group)
- The better ear has moderate, moderately severe, or severe hearing loss (based on the 2021 WHO hearing classification standards, i.e., PTA between 35～79dB).
- Wearing hearing aids for more than half a year, with daily wearing time exceeding 7.2 hours; (Only ARHL-HA group)
- Chinese nationals who can complete all assessments in Chinese.
- Right-handed.
- Educational level of at least 6 years.
- Informed consent obtained, agreeing to participate in the trial with no plans to relocate within one year.
You may not qualify if…
- Exclusion of hearing loss due to noise, genetics, ototoxic drugs, or other non-age-related causes;
- History of central nervous system disorders such as cerebral infarction, stroke, epilepsy, or traumatic brain injury;
- Diagnosis of dementia or other neurodegenerative diseases that affect compliance with the study;
- Presence of major neurological disorders, severe systemic diseases, family history of hereditary conditions, or major psychiatric disorders;
- Contraindications to MRI;
- Contraindications to rTMS.
Where it is running
- Sun Yat-sen Memorial Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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