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临床试验/NCT03122145
NCT03122145已完成1 期

Establishing Normal Swallowing and Breathing Profiles in Healthy Adults Across the Age Span

University of Florida1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2017年5月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
49
试验地点
1
主要终点
Duration of Laryngeal Vestibule Closure (dLVC)

研究概览

简要总结

The purpose of this study is to establish normative values for clinical testing measures of swallow, respiratory and cough functions. This will aide in establishing degree of impairment in disordered populations, and in identifying efficacious treatment paradigms for dysphagia.

详细描述

The prevalence of dysphagia may be as high as 22% in individuals over 50 years of age. There are few therapeutic options and minimal management strategies offered to treat these individuals and improve sequelae of dysphagia. Dysphagia contributes to malnutrition, aspiration, pneumonia, reduced quality of life and increased mortality in neurodegenerative disease such as ALS. One reason for this is the lack of normative data across various measures of swallowing and respiratory function. As a result, detecting early impairments in swallowing physiology is difficult, given the variability of swallowing and unknown normative value range of swallowing physiology. Therefore, the goal of this study is to complete clinical tests of swallowing and cough function in healthy volunteers to establish normative data. This will contribute to future study in disordered populations, to determine degree and severity of impairment and efficacious treatment and management strategies based on impairment.

The purpose of this study is to establish normative values for clinical testing measures of swallow, respiratory and cough functions. This will aide in establishing degree of impairment in disordered populations, and in identifying efficacious treatment paradigms for dysphagia.

研究设计

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

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Up to 120 individuals will be included in this study.
  • Subjects will include both male and females who are aged between 18-100
  • Healthy and with no major medical conditions.
  • No specific gender or race will be excluded or targeted for participation in this study.

排除标准

  • Adults who are pregnant
  • Those with major medical conditions (i.e., swallowing impairment, brain injury) will be excluded from this study.
  • Anyone with allergy to barium will be excluded from this study.

研究组 & 干预措施

Healthy Volunteers - Experiment 1

Experimental

This study will involve a single 60-minute visit. All women under the age of 62 will be asked to complete a pregnancy test as part of the screening process during to radiation exposure. Eligible participants will then undergo voluntary and reflexive cough testing. The entire duration of the exam will be under 60 minutes and the participant will be free to leave at any point during the examination.

干预措施: Capsaicin (Drug)

Healthy Volunteers - Experiment 1

Experimental

This study will involve a single 60-minute visit. All women under the age of 62 will be asked to complete a pregnancy test as part of the screening process during to radiation exposure. Eligible participants will then undergo voluntary and reflexive cough testing. The entire duration of the exam will be under 60 minutes and the participant will be free to leave at any point during the examination.

干预措施: Videofluoroscopic swallow study (Device)

Healthy Volunteers - Experiment 2

Experimental

This study will involve a single 60-minute visit. All women under the age of 62 will be asked to complete a pregnancy test as part of the screening process during to radiation exposure. Eligible participants will then undergo a instrumental swallowing evaluation (videofluoroscopy). The entire duration of the exam will be under 60 minutes and the participant will be free to leave at any point during the examination.

干预措施: Videofluoroscopic swallow study (Device)

结局指标

主要结局

Duration of Laryngeal Vestibule Closure (dLVC)

时间窗: Single Visit

LVC temporal measures will be used to calculate the duration of laryngeal vestibule closure (dLVC)

Laryngeal Vestibule Closure Reaction Time (LVCrt)

时间窗: Single Visit

LVC temporal measures will be used to calculate the laryngeal vestibule closure reaction time (LVCrt)

Reflexive Cough Testing (With Urge-to-Cough)

时间窗: Single assessment time period

Reflexive cough testing will use a capsaicin challenge that will assess individual's cough motor and cough sensory thresholds. A modified Borg scale ranging from 0 (no cough) to 10 (maximal urge to cough) will be used to quantify these thresholds. A cough sensory threshold will be defined as a concentration of capsaicin eliciting a perceived urge to cough of 1 (very slight) \>2/3 trials. A cough motor threshold will be the lowest concentration of capsaicin eliciting \>2 cough responses in 2/3 trials.

次要结局

  • Voluntary Peak Cough Flow Testing (With Electronic Peak Cough Flow Meter Device)(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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