What is this study trying to find out about age-related hearing loss?

This study is evaluating whether using hearing aids can slow down cognitive decline in older adults with age-related hearing loss. Researchers want to see how hearing improvement affects memory and thinking skills over time. The study is sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.

Who may be eligible for this age-related hearing loss clinical trial?

Adults aged 60 to 85 with sensorineural hearing loss and a diagnosis of presbycusis may be eligible. Participants need to have certain scores on cognitive tests like the MMSE and MoCA and must not have profound hearing loss or cochlear implants. Please review eligibility criteria for more details.

Is there any cost to participate in this age-related hearing loss clinical trial?

Study-related care, including the hearing aids and all trial visits, is provided at no cost. However, personal travel expenses to attend visits may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 60Years - 85Years

All Genders

Healthy Volunteers

ID05694039

Study on Cognitive Changes in Older Adults with Age-Related Hearing Loss Using Hearing Aids Over 5 Years

Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2023-01-23

388

Participants Needed

Research Sites

N/A

Total Duration

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

Age: 60Years - 85Years

All Genders

Healthy Volunteers

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

Research Team

Minqian Gao, B.sc

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