Changes in Sensitivity of Swallowing-relevant Structures, Taste and Smell in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Dysphagia
研究概览
简要总结
This study evaluates changes in swallowing using endoscopic swallowing studies and measuring of pharyngeal sensitivity, taste and smell in stroke patients. Younger (<60 years) and older (>60 years) volunteers will serve as control.
详细描述
Stroke is the second leading cause of death. At least 50% of stroke patients develop dysphagia, leading to aspiration pneumonia, which is the main cause of death in stroke [2].
It is assumed that normal sensitivity is vital for aspiration-free swallowing and for the triggering of the swallowing reflex.
Ali et al. demonstrated aspiration-free swallowing in healthy volunteers who underwent local anaesthesia of oral and pharyngeal structures [1]. Power et al. showed a reduced sensitivity of pharyngeal structures in stroke patients prone to aspiration [3].
By combining measuring sensitivity and flexible endoscopic swallowing studies, this study further investigates the role of sensitivity in swallowing Neuropsychological deficits of swallowing, such as swallowing apraxia or buccal hemineglect, is assessed by neuropsychological testing.
Additionally, there is no systematic research investigating the change in smell and taste in correlation with changes in stroke patients
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers:
- •informed consent
- •Stroke patients:
- •informed consent
- •new supratentorial stroke (<72 hours old) confirmed by CT (computed tomography) or MRI (magnetic resonance imaging)
排除标准
- •pre-existing stroke oder dysphagia
- •extensive white matter lesions in CT- or MRI-scan
- •allergies to odorous substances or flavoring
- •contraindications for FEES (flexible endoscopic evaluation of swallowing), CT or MRI (stroke patients only)
结局指标
主要结局
Dysphagia
时间窗: 96 hours after initial symptoms
Changes found in endoscopic swallowing study : Presence and severity of dysphagia (measured with Rosenbek's Penetration/Aspiration-scale)
次要结局
- Neuropsychological deficits(96 hours after initial symptoms)
- Lesion site(96 hours after initial symptoms)
- Taste/Smell(96 hours after initial symptoms)
- Sensitivity(96 hours after initial symptoms)
研究者
Tobias Braun
Principal Investigator
University of Giessen