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临床试验/NCT04385225
NCT04385225Unknown不适用

Effect of Hearing Loss and Vestibular Decline on Cognitive Function in Older Subjects: Correlation With Cortical Auditory Evoked Potentials and MRI Brain Volume Changes

University Hospital, Antwerp1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年12月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Change in Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals total score

研究概览

简要总结

The world population has been growing and aging dramatically, with a rising prevalence of dementia. Worldwide, around 50 million people have dementia, with 10 million new cases added every year. Despite the epidemic scale of dementia, until now no cure or disease-modifying therapy has been identified. Therefore, the World Health Organization (WHO) has recognized dementia as a public health priority. Several large studies have demonstrated that hearing impairment is associated with a greater risk of cognitive impairment. Hearing rehabilitation could potentially provide a disease-modifying therapy to delay cognitive decline. Although auditory behavioral research has not yet revealed a reliable indicator of early cognitive impairment, cortical-evoked auditory potentials (CAEP) have shown promising evidence as a non-invasive way to identify early-stage cognitive impairment.

The peripheral vestibular apparatus is located in the inner ear and codes rotation and translation of the head to preserve a stable view. Increasing evidence suggests that bilateral vestibular function loss, also known as bilateral vestibulopathy (BVP), leads to hippocampal atrophy and reduced spatial cognitive skills, as well as structural and functional alterations in parieto-insular and parieto-temporal regions. Many studies have demonstrated that vestibular function declines with age. Vestibular dysfunction can be linked to reduced topographical orientation and memory and has been suggested as a risk factor to AD, due to increased risk of falling and deficits in activities of daily life (ADL).

Our first aim is to study the effect of SNHL and vestibular decline on CAEP, spatial and non-spatial cognitive functioning and trajectories in cognitively healthy older subjects, as well as patients with mild cognitive impairment (MCI) and AD. Our second aim is to study if MRI brain volume changes can be observed in the hippocampus, entorhinal cortex, and auditory and vestibular key regions in these populations and correlate with CAEP and cognitive functioning.

The expected outcome is important to society because it will provide data from a cognitive assessment protocol adapted for a potentially hearing-impaired population, objective outcome measures (incl. CAEP and MRI brain volume changes) to identify older subjects with SNHL and BVP at risk for cognitive decline, and will support screening and interventional studies to assess the impact of rehabilitation on slowing down cognitive decline.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Mini Mental State Examination > 12
  • •Dutch-speaking

排除标准

  • •Uncorrectable visual impairment
  • •Hearing implants
  • •Hearing aids

研究组 & 干预措施

Alzheimer's Disease

Other

Alzheimer's Disease

干预措施: Longitudinal follow-up (Other)

Healthy controls

Other

Age-matched controls with normal hearing or mild sensorineural hearing loss: 40 decibel or less in better hearing ear, and normal vestibular function

干预措施: Longitudinal follow-up (Other)

Moderate Sensorineural hearing loss

Other

Moderate Sensorineural hearing loss: 41-60 decibel in the better hearing ear

干预措施: Longitudinal follow-up (Other)

Severe Sensorineural hearing loss

Other

Severe Sensorineural hearing loss: 61-80 decibel in the better hearing ear

干预措施: Longitudinal follow-up (Other)

Bilateral Vestibulopathy

Other

Bilateral vestibulopathy: half with normal hearing, half with severe to profound sensorineural hearing loss

干预措施: Longitudinal follow-up (Other)

Mild Cognitive Impairment

Other

Mild Cognitive Impairment

干预措施: Longitudinal follow-up (Other)

结局指标

主要结局

Change in Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals total score

时间窗: Longitudinal follow-up for 24 months

Cognitive test adapted for hearing impaired subjects, minimum score is 200, maximum score is 800, higher scores indicate better cognitive performance

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ethisch Comité, UZA

Prof. dr. Vincent Van Rompaey, principal investigator

University Hospital, Antwerp

研究点 (1)

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