Trials / Recruiting
RecruitingNCT05694039
A Prospective Cohort Study On Change of Cognitive Function In Aged-related Hearing Loss With Hearing Aids
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 388 (estimated)
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
- Sex
- All
- Age
- 60 Years – 85 Years
- Healthy volunteers
- Accepted
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.
Detailed description
Materials and methods: The unicentric, prospective cohort study included 388 patients with presbycusis aged 60-85 who were recruited in the Department of Otorhinolaryngology from March 2022 to March 2028. They were averagely divided into the control group (n = 194) and the intervention group (n = 194). The post intervention group received hearing aid intervention, and was followed up for 5 years, once every six months. Audiological assessment, cognitive function assessment, noninvasive brain imaging assessment and hearing aid effect assessment were performed at baseline and each follow-up. This thesis aim to investigate the changes of cognitive function in senile deafness under the intervention of hearing aids.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Hearing Aids | The intervention group uses hearing aids, and the intervention group receives hearing aid intervention for 5 years. |
Timeline
- Start date
- 2022-03-09
- Primary completion
- 2028-03-09
- Completion
- 2028-03-09
- First posted
- 2023-01-23
- Last updated
- 2023-01-23
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05694039. Inclusion in this directory is not an endorsement.