预测吞咽困难结果的新型咽部指标
使用高分辨率测压法定义新的咽压指标以预测吞咽困难治疗结果和临床预后
这项多中心试验将跟踪一群患有吞咽困难的退伍军人，为期 8 周，他们将接受临床指导的口咽锻炼，口咽强化是主要目标。 患有吞咽困难的退伍军人将在三个时间点进行评估：基线、治疗开始后 4 周和治疗开始后 8 周。 非吞咽困难的退伍军人对照组也将在平行时间点进行数据收集，而无需完成治疗范例。 然后，研究人员将使用测压法、视频透视、饮食评估、功能储备测试和患者报告的结果测量将患者与非吞咽困难对照进行比较。
研究人员的目标是 1) 量化吞咽困难治疗引起的吞咽功能压力测量的变化； 2) 确定护理标准和/或基于压力的指标的哪种组合最能跟踪结果指标； 3) 开发预测治疗成功的多模式预后算法。 本研究将建立适用于吞咽困难临床护理和研究的精确结果测量范式，从而提高临床信心并为退伍军人吞咽困难康复的个性化医学方法铺平道路。
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Illinois
-
Hines、Illinois、美国、60141-3030
- Edward Hines Jr. VA Hospital, Hines, IL
-
-
Ohio
-
Cincinnati、Ohio、美国、45220-2213
- Cincinnati VA Medical Center, Cincinnati, OH
-
-
Wisconsin
-
Madison、Wisconsin、美国、53705-2254
- William S. Middleton Memorial Veterans Hospital, Madison, WI
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准：
- 签署知情同意书
- 接受语言病理学家的吞咽困难诊断
- 必须制定以加强口咽肌肉组织为目标的吞咽困难治疗计划
- 英语会话
排除标准：
- 钡过敏史
- 对局部麻醉剂有过敏反应史
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：患者组
语言强化
|
标准或护理语言强化方法，结果用新的压力指标衡量
|
|
无干预：控制
无吞咽困难（吞咽障碍）病史或轻微至轻度吞咽困难，不需要强化计划
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
pHRM Pressure Change (Pharyngeal)
大体时间：Baseline and 8 weeks
|
Will assess the change in pressure by pharyngeal high resolution manometry over the time frame. The primary measure of interest is Integral Pressure during the 10 mL swallow at the tongue base. This is measured in two forms: 1. Pharyngeal Contractile Integral (PhCI): range is between 100 and 600 mmHg·s·cm ; 2. Mesopharyngeal Max Pressure (tongue base): range is between ~115-210 mmHg in healthy adults. Positive change would be a movement toward normal range of pressure. This metric is measured automatically in both Software systems used to evaluate pharyngeal pressure (WiscMano and Swallow gateway). |
Baseline and 8 weeks
|
|
pHRM Pressure Change (Mesopharyngeal)
大体时间：Baseline and 8 weeks
|
Will assess the change in pressure by pharyngeal high resolution manometry over the time frame. The primary measure of interest is Integral Pressure during the 10 mL swallow at the tongue base. This is measured in two forms: 1. Pharyngeal Contractile Integral (PhCI): range is between 100 and 600 mmHg·s·cm ; 2. Mesopharyngeal Max Pressure (tongue base): range is between ~115-210 mmHg in healthy adults. Positive change would be a movement toward normal range of pressure. This metric is measured automatically in both Software systems used to evaluate pharyngeal pressure (WiscMano and Swallow gateway). |
Baseline and 8 weeks
|
|
Swallowing Clinical and Fluoroscopic Change (MBSImP)
大体时间：Baseline and 8 weeks
|
Will assess the change in fluoroscopy and clinical assessments over the time frame.
The primary tool of measurement is the combined score of the Modified Barium Swallow Impairment Profile (MBSImP).
This is a 17 item standardized tool to measure impairment of swallow identified using contrast barium swallows.
The investigators will use the composite pharyngeal score which ranges from 0 to 3, the higher the score the more abnormal the swallow function, Normal swallows will score 5 or less and severe dysphagia will score 9 or higher.
Movement toward 0 is a positive or improved swallow function, movement toward 23 is negative or worsening swallow function and full range is from 0 to 29 with a higher score indicating worse impairment.
Scores under 13 indicate the mild or no impairment.
|
Baseline and 8 weeks
|
|
Patient Reported Outcome Changes (SSQ)
大体时间：Baseline and 8 weeks
|
The Sydney Swallowing Questionnaire (SSQ) is a patient reported symptom scale with 17 questions, each scaled from 0+ no dysfunction to 100 equal extreme dysfunction using a 100mm visual analogue scale with 0 and 100 as anchors.
The total score can be recorded for 0 to 1700.
Normal swallowers will average 40 with a range of 200 to 0. Dysphagia patients average 800 with a range of 150 to 1600.
Movement toward 0 will be considered an improvement, movement toward 1700 worsening in swallowing ability preserved by the patient.
|
Baseline and 8 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient Reported Outcome Changes (EAT-10)
大体时间：Baseline and 8 weeks
|
The Eating Assessment Tool-10 (EAT-10) is a short 10 question swallowing assessment tool with 10 questions each scaled 0 to 4, total can be between 0 and 40.
The normal swallowers will score under 2. Changes toward 0 will be identified as improved swallow symptom function, changes toward 40 worsening symptoms.
|
Baseline and 8 weeks
|
|
Patient Reported Outcome Changes, Diet Change
大体时间：Baseline, 4 weeks, and 8 weeks
|
International Dysphagia Diet Standardization initiative, Functional Oral Intake scale.
Standardize scale of diet (liquid and solid food, iddsi.org).
Foods scaled from regular diet 7 to liquidized 3, and liquids scaled from thin liquids 0 to extremely thick 4. Improvement in diet will be report if patients move toward 0 in liquid intake and toward 7 in solid food intact, and movement in the opposite directions will be evidence of poorly food and liquid tolerance.
|
Baseline, 4 weeks, and 8 weeks
|
合作者和调查者
调查人员
- 首席研究员：Timothy M. McCulloch, MD、William S. Middleton Memorial Veterans Hospital, Madison, WI
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.