NCT05694039 A Prospective Cohort Study On Change of Cognitive Function In Aged-related Hearing Loss With Hearing Aids
| NCT ID | NCT05694039 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
| Condition | Age-related Hearing Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 388 participants |
| Start Date | 2022-03-09 |
| Primary Completion | 2028-03-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 388 participants in total. It began in 2022-03-09 with a primary completion date of 2028-03-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05694039 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 85 Years, studying Age-related Hearing Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05694039 currently recruiting?
Yes, NCT05694039 is actively recruiting participants. Contact the research team at gaomq6@mail.sysu.edu.cn for enrollment information.
Where is the NCT05694039 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT05694039 clinical trial?
NCT05694039 is sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. The trial plans to enroll 388 participants.