Efficacy and Safety of rTMS Combined With HA in the Treatment of Cognitive Decline in Aged Relate… (NCT07389213) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy and Safety of rTMS Combined With HA in the Treatment of Cognitive Decline in Aged Related Hearing Loss
China189 participantsStarted 2025-05-01
Plain-language summary
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.
Who can participate
Age range50 Years – 85 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
What they're measuring
1
Montreal Cognitive Assessment(MoCA ) improvement value
Timeframe: Baseline、Post-intervention 2 weeks and Post-intervention 1 month
Trial details
NCT IDNCT07389213
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University