Characterizing Oral and Swallowing Function in Older Adults Presenting to the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Positive oropharyngeal dysphagia screen prevalence
研究概览
简要总结
The purpose of this study is to learn about oral and swallowing function in older adults presenting to the emergency department. The hypothesis is that older adults often have problems with oral and swallowing function and these problems relate to other conditions. Study activities are done during the emergency department visit and include providing saliva samples, completing a bedside water swallow test, completing oral function assessments, completing respiratory function tests, and answering survey questions.
详细描述
Oropharyngeal dysphagia is characterized by changes in swallow event timing, biomechanics, and pressure generation that occur with advancing age resulting in aspiration of bacteria-laden saliva, food, and liquid into the lungs. Currently, oral and swallowing function is not routinely or comprehensively assessed in older adults despite poor oral health and oropharyngeal dysphagia being known risk factors for pneumonia, the leading infectious cause of mortality among adults 65+. This study seeks to extensively characterize oral and swallowing function in older adults presenting to the emergency department to clarify the relationship of oral hypofunction, dysphagia, and the upper airway microbiome. To achieve this aim, study procedures include a bedside dysphagia screen, oral health assessment, tongue pressure measurement, masticatory function assessment, respiratory function tests, salivary compositional analysis, oral microbiome analysis, and microphysiological system analysis which applies saliva samples to a bronchiolar lumen model to mimic aspiration and quantify cellular and tissue responses to the saliva microbiome and secreted mediators.
Per amendment approved 10/29/2025: Saliva samples for microbiota analysis will not be collected from participants enrolled after 10/22/2025.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically stable and able (not NPO) to safely drink water and eat a saltine cracker per ED provider
排除标准
- •Non-English speaking
结局指标
主要结局
Positive oropharyngeal dysphagia screen prevalence
时间窗: During emergency department visit, approximately 2-5 minutes for bedside dysphagia screen and 5-10 minutes for patient reported swallowing function
Number of participants with positive oropharyngeal dysphagia screen identified through bedside dysphagia screen and patient reported swallowing function
次要结局
- Gene expression(During emergency department visit, up to 10 minutes for saliva collection)
- Immune cell trafficking(During emergency department visit, up to 10 minutes for saliva collection)
- Oral dryness prevalence(During emergency department visit, up to 10 minutes for saliva collection)
- Decreased tongue pressure prevalence(During emergency department visit, approximately 2-5 minutes)
- Oral microbiome(During emergency department visit, up to 10 minutes for saliva collection)
- Cell barrier function(During emergency department visit, up to 10 minutes for saliva collection)
- Protein composition(During emergency department visit, up to 10 minutes for saliva collection)
- Decreased masticatory function prevalence(During emergency department visit, approximately 2-5 minutes)
- pH of saliva sample(During emergency department visit, up to 10 minutes for saliva collection)
- Mean brief oral health status examination (BOHSE) score(During emergency department visit, approximately 2-5 minutes)
- Salivary Substance P Concentration(During emergency department visit, up to 10 minutes for saliva collection)
- Immunofluorescent staining(During emergency department visit, up to 10 minutes for saliva collection)
- Extensional viscosity of saliva sample(During emergency department visit, up to 10 minutes for saliva collection)