Actively Recruiting
A Prospective Cohort Study on Cognitive Changes in Age-Related Hearing Loss Using Hearing Aids
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2023-01-23
388
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how hearing aids might affect cognitive function in older adults with age-related hearing loss, also known as presbycusis. This study focuses on individuals aged 60 to 85 and aims to understand whether improving hearing ability can slow down the decline in memory and cognition associated with hearing loss. The research is being conducted at a single center and plans to follow participants for several years to assess changes over time. Participants are divided into two groups: one group receives hearing aids and the other does not receive any intervention. Those in the hearing aid group will use the device continuously for five years. Follow-up visits occur every six months, during which various tests are performed, including hearing assessments, cognitive tests, and brain imaging. The study uses a double-blind, randomized design to compare outcomes between the groups. Throughout the study, participants will have their cognitive functions measured using tools like the Montreal Cognitive Assessment (MoCA) and the Mini-Mental Status Exam (MMSE) every six months. Hearing ability will also be evaluated regularly through audiometry tests. Researchers will monitor the effects of hearing aids on cognitive decline and hearing improvement over the five-year period. Safety and adherence to the hearing aid intervention will be tracked as well.
CONDITIONS
Brief Title
A Prospective Cohort Study On Change of Cognitive Function In Aged-related Hearing Loss With Hearing Aids
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 60 and 85 years
- Sensorineural hearing loss with pure-tone thresholds between 25 and 70 dB HL at octave frequencies from 250 to 4000 Hz
- Four frequency pure tone average (PTA) of at least 30 dB HL and PTA no more than 90 dB HL
- Diagnosed with presbycusis (age-related hearing loss)
- Mini-Mental Status Exam (MMSE) score of 23 or below
- Montreal Cognitive Assessment (MoCA) score of 22 or below
You will not qualify if you...
- Hearing loss too severe to be helped by hearing aids (profound hearing loss)
- History of significant ear or neurological disorders
- Hearing loss treated with cochlear implants (cannot use hearing aids)
- Any unstable or progressive medical condition considered clinically significant
- Any condition that the investigator believes makes participation unsafe
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 years
Participants in the intervention group use hearing aids as part of the study intervention for 5 years. The control group does not receive any intervention.
Visits every 6 months for assessments
Duration - 5 years
Participants are followed up regularly to assess changes in cognitive function, hearing, and hearing aid effects over time.
Visits every 6 months for assessments
Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
M
Minqian Gao, B.sc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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