rTMS plus hearing aids to help thinking in age-related hearing loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.