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NCT Number: NCT02183519

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

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.

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Key information

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Center for Movement Disorders and Neurorestoration, Gainesville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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)

Treatment and study plan

Capsaicin

Drug

For reflex cough testing, all participants will receive various concentrations of nebulized capsaicin. Delivery of multiple concentrations and doses of capsaicin allows for accurate assessment of both the strength (airflow measures) of reflex, as well as cough sensitivity.

Voluntary cough test

Other

Participants will be fitted with a facemask covering their mouth and nose, and instructed to cough into the facemask.

Primary outcomes

  1. Peak Expiratory Flow Rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 8, 2014
Registry last updated
Mar 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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