Investigating cognitive function changes in older adults with hearing loss using hearing aids
A Prospective Cohort Study On Change of Cognitive Function In Aged-related Hearing Loss With Hearing Aids
NA · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · NCT05694039
This study is testing if using hearing aids can help older adults with hearing loss think better and lower their chances of developing dementia.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 388 (estimated) |
| Ages | 60 Years to 85 Years |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (other) |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05694039 on ClinicalTrials.gov |
What this trial studies
This prospective cohort study aims to evaluate the impact of hearing aids on cognitive function in older adults aged 60-85 with age-related hearing loss. A total of 388 participants will be divided into a control group and an intervention group, with the latter receiving hearing aids and undergoing assessments over a five-year period. The study will include audiological evaluations, cognitive function tests, and brain imaging to determine the effectiveness of hearing aids in slowing cognitive decline and reducing dementia risk. The research is particularly focused on the long-term benefits of auditory intervention in this demographic.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 60-85 with sensorineural hearing loss and mild cognitive impairment.
Not a fit: Patients with profound hearing loss or those who have received cochlear implants will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cognitive health and reduced dementia risk for older adults with hearing loss.
How similar studies have performed: Previous studies have indicated that auditory interventions can positively affect cognitive function, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age\>60yrs，≤85yrs（MCI prevalence was 6.7% for ages 60-64, 8.4% for 65-69, 10.1% for 70-74, 14.8% for 75-79,and25.2% for80-84）; Sensorineural Hearing loss with pure-tone thresholds 25-70 dB HL at octave frequencies between 250 and 4000 Hz, 4 frequency PTA of ≥ 30 dB HL, and the PTA ≤ 90 dB HL; Diagnosed as Presbycusis; Score of 23 or below on Mini-Mental Status Exam (MMSE); Score of 22 or below on Montreal Cognitive Assessment (MoCA); Exclusion Criteria: Hearing loss exceeding the limits that can be successfully aided with hearing aids (i.e., profound hearing loss); Significant history of otologic or neurologic disorders; Hearing loss remediated with a cochlear implant (cannot wear hearing aids); Any clinically significant unstable or progressive medical condition; Any condition which, in the opinion of the investigator, places the participant at unacceptable risk if he or she were to participate in the study.
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: Minqian Gao, B.sc
- Email: gaomq6@mail.sysu.edu.cn
- Phone: 13660778861
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.
Conditions: Age-related Hearing Loss, Hearing Loss, Sensorineural, Hearing Aid, Cognitive Function Abnormal