The Brain&Senses Study Impact of Multi Sensory Impairments on the Progression of Cognitive Decline and Reduction of Quality of Life in People Over 50ies
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Impact of hearing loss, vertigo and smell loss on cognition
研究概览
简要总结
The aim of this longitudinal observational study is to evaluate the impact of sensory deficits (smell, hearing and balance on cognitive decline and quality of life in the medium term (5 years)) on a population of patients over 55.
Patients will be evaluated by a neurologist, a neuropsychologist and an otolaryngologist who will perform olfactory, auditory and vestibular tests.
The acquired data will then be analyzed with multivariate analysis to understand the effect of multisensory deficit on both cognition and quality of life with a particular focus on depression.
The primary objective will be the evaluation of multiple deficits on cognition, the secondary will be aimed at understanding whether one sensory deficit more than another, e.g. smell versus hearing, will have a greater impact on the patient's conditions.
详细描述
Evaluation protocol
Enrollment phase: the subjects will be recruited through recruitment at the Department of Neurology of the Fano hospital and the various associations supporting patients with cognitive impairment in the area. The subjects who meet the inclusion and exclusion criteria for the cohort will be contacted and invited for the ENT evaluations that will be carried out in the Department of Otolaryngology of the FANO hospital.
Inclusion criteria: patients between 60 and 85 years of age, in general good health, in the absence of known severe psychiatric disorders, available to be included in the study and to follow the 5-year follow-up.
Exclusion criteria: Obstructive nasal problems, Previous endoscopic nose + paranasal sinus surgery, Chronic use of cortisone spray and/or systemic, Subjects with previous stroke and outcomes, Subjects with history of stroke in the last 3 years without outcomes, Head trauma in the last 24 months, Previous ear surgery, Patients who have been exposed to chemical agents without protection for work, e.g. carpenters and previous Covid with outcomes (olfactory, vestibular, auditory and cognitive "brain fog")
Neurology
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 60 and 85 years of age
- •in general good health
- •the absence of known severe psychiatric disorders
- •available to be included in the study and
- •to follow the 5-year follow-up.
排除标准
- •Obstructive nasal problems
- •Previous endoscopic nose + paranasal sinus surgery
- •Chronic use of cortisone spray and/or systemic
- •Subjects with previous stroke and outcomes
- •Subjects with history of stroke in the last 3 years without outcomes
- •Head trauma in the last 24 months
- •Previous ear surgery
- •Patients who have been exposed to chemical agents without protection for work, e.g. carpenters
- •previous Covid with outcomes (olfactory, vestibular, auditory and cognitive "brain fog")
结局指标
主要结局
Impact of hearing loss, vertigo and smell loss on cognition
时间窗: 5 years
All these measures are numeric. Vertigo will be yes (1) or no (0), same for hearing loss and smell loss
次要结局
未报告次要终点
研究者
Arianna Di Stadio
Associate Professor of Otolaryngology
University of Campania Luigi Vanvitelli