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临床试验/NCT02183519
NCT02183519已完成1 期

Respiratory Kinematics of Reflex and Voluntary Cough in Healthy Older Adults and Parkinson's Disease

University of Florida2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2014年10月最近更新:
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
44
试验地点
2
主要终点
Peak Expiratory Flow Rate

研究概览

简要总结

The purpose of this research study is to test cough function in individuals with Parkinson's disease and healthy older adults. Cough is a complex, defensive function which involves movement of the chest and lungs. The investigators want to compare the movement of the chest wall and the lungs during voluntary and reflex cough.

The long-term goal of this research is to develop treatments for people with cough dysfunction. Cough dysfunction increases the risk for respiratory infections such as pneumonia. The results from this study will provide information to help researchers understand the difference between reflex and voluntary cough more fully.

详细描述

If the participant agrees to participate, the investigators will first test pulmonary (lung) function. Next, the investigators will test voluntary and reflex cough. After this first round of cough testing, the investigators will ask participants to cough long and hard during voluntary and reflex cough testing. Finally, the investigators will view the larynx (voice box) with an endoscopic camera inserted through the nose. This test is done to see if there are any changes in the larynx that may influence cough.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

  1. baseline respiratory maneuvers for calibration of the Respitrace system with spirometry 2) sequential voluntary cough (no cueing), 3) reflex cough sensitivity testing to establish the lowest concentration of capsaicin that elicits a two cough response (C2) (no cueing), 4) randomized production of sequential voluntary cough (3x) or reflex cough induced with C2 (3x) with cueing to 'cough long and hard' and 5) flexible laryngoscopy to assess age-related changes to the larynx that may impact cough function.

入排标准

年龄范围
55 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 55-85 years
  • Ability to provide informed consent
  • For participants with Parkinson's disease (PD):
  • Diagnosis of PD (Hoehn & Yahr stages II-IV) by a University of Florida Movement Disorders fellowship trained neurologist having completed a clinical assessment of each participant's PD severity and arriving at the diagnosis of PD by applying strict United Kingdom brain bank criteria.

排除标准

  • Participants with PD:
  • History of neurological disorders other than PD (e.g. multiple sclerosis, stroke, brain tumor, etc)
  • Healthy older adults:
  • History of neurological disease including PD
  • History of head and neck cancer
  • History of breathing disorders or disease (i.e. chronic obstructive pulmonary disease, asthma)
  • History of smoking for more than 5 years at any one time (as this reduces the sensitivity to capsaicin)
  • History of chest infection the last 5 weeks
  • Failure of a screening test of pulmonary function (e.g. forced expiratory volume in one second/forced vital capacity<75%)
  • Difficulty complying due to neuropsychological dysfunction (i.e. severe depression)

研究组 & 干预措施

Healthy older adults

Experimental

All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.

干预措施: Capsaicin (Drug)

Healthy older adults

Experimental

All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.

干预措施: Voluntary cough test (Other)

Parkinson's disease

Experimental

All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.

干预措施: Capsaicin (Drug)

Parkinson's disease

Experimental

All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.

干预措施: Voluntary cough test (Other)

结局指标

主要结局

Peak Expiratory Flow Rate

时间窗: 1-2 hours

Peak expiratory flow rate is the maximum volume of air that is expelled per unit time for each cough in a cough epoch. Measured in liters/second.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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