HIV/AIDS Clinical Trials

Find HIV/AIDS Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 85
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Yang Haidi, PhD
yanghaidi1978@163.com
13178821663
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 189
Treatments
Experimental: ARHL-nonHA group
This study will use repetitive transcranial magnetic stimulation (rTMS) as an intervention. Participants will be right-handed Chinese individuals aged between 50 and 85 years, diagnosed with moderate to severe age-related hearing loss (pure-tone average PTA of the better ear ranging from 35 to 79 dB), meeting the diagnostic criteria outlined in the 2019 expert consensus. Eligible participants must have at least 6 years of education and be able to complete all assessments in the Chinese version.
Experimental: ARHL-HA group
This study will use repetitive transcranial magnetic stimulation (rTMS) as an intervention. Participants will be right-handed Chinese individuals aged between 50 and 85 years, diagnosed with moderate to severe age-related hearing loss (pure-tone average PTA of the better ear ranging from 35 to 79 dB).Participants must have been wearing hearing aids for more than six months and use them for over 7.2 hours daily. Eligible participants must have at least 6 years of education and be able to complete all assessments in the Chinese version.
No_intervention: HC group
Aged between 50 and 85 years, with no gender restriction; pure-tone average (PTA) ≤25 dB HL in the better ear; Chinese nationality, able to complete all Chinese-version assessments; right-handed; and with at least 6 years of education.
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

This content was sourced from clinicaltrials.gov