rTMS plus hearing aids to help thinking in age-related hearing loss
Efficacy and Safety of rTMS Combined With HA in the Treatment of Cognitive Decline in Aged Related Hearing Loss: A Single-Center Real-World Study
This study will test whether daily high-frequency rTMS added to usual care can improve thinking skills and brain activity in older adults with age-related hearing loss, both those who do and do not use hearing aids, compared with older adults with normal hearing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 189 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07389213 on ClinicalTrials.gov |
What this trial studies
This is a real-world interventional study enrolling 189 older adults divided into three groups: age-related hearing loss without hearing aids (ARHL-nonHA), age-related hearing loss with hearing aids (ARHL-HA), and healthy older adults with normal hearing (HC). All participants will receive audiological, cognitive (MMSE, MoCA, SCWT, DST, TMT), mood and sleep (GDS-15, HAMD-24, PSQI), and brain imaging assessments (EEG, sMRI, rs-fMRI, task-fMRI). Participants in the two ARHL groups will receive two 14-day courses of daily high-frequency rTMS, with repeat assessments one month after treatment. Data will be analyzed to see if rTMS combined with hearing-aid use improves cognition and to explore associated brain changes.
Who should consider this trial
Good fit: Ideal candidates are Chinese-speaking adults aged 50–85 with age-related, symmetrical high-frequency hearing loss (better-ear PTA 35–79 dB) who meet handedness and education requirements, including a subgroup who have used hearing aids for >6 months with >7.2 hours/day wear.
Not a fit: People with normal hearing, hearing loss from non-age-related causes, very mild hearing loss outside the PTA range, severe uncontrolled medical or psychiatric conditions, or who cannot undergo rTMS/MRI may not benefit from this intervention.
Why it matters
Potential benefit: If successful, combining rTMS with hearing-aid use could improve cognitive performance and related brain function in older adults with age-related hearing loss.
How similar studies have performed: Previous studies have reported mixed but sometimes positive cognitive effects from rTMS and modest cognitive associations with hearing-aid use, while combining rTMS and hearing aids for age-related hearing loss remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥50 years and ≤85 years, regardless of gender. 2. 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) 3. 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). 4. Wearing hearing aids for more than half a year, with daily wearing time exceeding 7.2 hours; (Only ARHL-HA group) 5. Chinese nationals who can complete all assessments in Chinese. 6. Right-handed. 7. Educational level of at least 6 years. 8. Informed consent obtained, agreeing to participate in the trial with no plans to relocate within one year. Exclusion Criteria: 1. Exclusion of hearing loss due to noise, genetics, ototoxic drugs, or other non-age-related causes; 2. History of central nervous system disorders such as cerebral infarction, stroke, epilepsy, or traumatic brain injury; 3. Diagnosis of dementia or other neurodegenerative diseases that affect compliance with the study; 4. Presence of major neurological disorders, severe systemic diseases, family history of hereditary conditions, or major psychiatric disorders; 5. Contraindications to MRI; 6. Contraindications to rTMS.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen Memorial Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Yang Haidi, PhD
- Email: yanghaidi1978@163.com
- Phone: 13178821663
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.