Actively Recruiting

Phase Not Applicable
Age: 60Years - 85Years
All Genders
Healthy Volunteers
NCT05694039

A Prospective Cohort Study On Change of Cognitive Function In Aged-related Hearing Loss With 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

313 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Background: Deafness is one of the nine potentially modifiable risk factors for dementia simulated by the Lancet dementia Prevention, intervention and Care Committee in 2017. Some studies have found that the risk factors of dementia in deafness system, with the increase of the degree of deafness, the risk of cognitive decline increases, while after long-term wear of hearing aids, the deterioration of immediate and delayed memory is less, and the possibility of cognitive decline slows down. Therefore, it is necessary for us to improve the auditory ability of patients with deafness through auditory intervention, so as to slow down its effect on dementia and reduce the incidence of dementia. At present, auditory intervention methods include hearing aid wearing and cochlear implant. However, there are few studies on cognitive function of presbycusis patients in China, and there is no research on how many years of auditory intervention can effectively slow down the incidence of dementia in presbycusis patients with MCI. Therefore, we intend to conduct a prospective cohort study on the changes of cognitive function of presbycusis under hearing aid intervention.

CONDITIONS

Official 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

Eligible

You may qualify if you...

  • Age greater than 60 years and up to 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 not exceeding 90 dB HL
  • Diagnosed with presbycusis
  • Score of 23 or below on Mini-Mental Status Exam (MMSE)
  • Score of 22 or below on Montreal Cognitive Assessment (MoCA)
Not Eligible

You will not qualify if you...

  • Hearing loss too severe to be helped by hearing aids (profound hearing loss)
  • Significant history of ear or neurological disorders
  • Hearing loss treated with cochlear implant and cannot wear hearing aids
  • Any clinically significant unstable or progressive medical condition
  • Any condition judged by the investigator as putting the participant at unacceptable risk for study participation

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China, 510000

Actively Recruiting

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Research Team

M

Minqian Gao, B.sc

CONTACT

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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