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

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ClinicalTrials.gov Identifier: NCT02183519
Recruitment Status : Completed
First Posted : July 8, 2014
Results First Posted : March 24, 2017
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE July 2, 2014
First Posted Date  ICMJE July 8, 2014
Results First Submitted Date  ICMJE February 2, 2017
Results First Posted Date  ICMJE March 24, 2017
Last Update Posted Date March 24, 2017
Study Start Date  ICMJE October 2014
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 2, 2014)
  • Lung volume initiation [ Time Frame: 1-2 hours ]
    Lung volume initiation is the volume of air in the lungs prior to production of the expiratory phase of cough.
  • Lung volume excursion [ Time Frame: 1-2 hours ]
    Lung volume excursion represents the total volume of air expelled during a cough.
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Respiratory Kinematics of Cough in Healthy Older Adults and Parkinson's Disease
Official Title  ICMJE Respiratory Kinematics of Reflex and Voluntary Cough in Healthy Older Adults and Parkinson's Disease
Brief Summary

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.

Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants with Parkinson's Disease are evaluated in parallel against a control group of health older adults
Masking: None (Open Label)
Masking Description:
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.
Primary Purpose: Treatment
Condition  ICMJE
  • Cough
  • Parkinson's Disease
Intervention  ICMJE
  • Drug: Capsaicin
    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.
  • Other: Voluntary cough test
    Participants will be fitted with a facemask covering their mouth and nose, and instructed to cough into the facemask.
Study Arms  ICMJE
  • Experimental: Healthy older adults
    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.
    Interventions:
    • Drug: Capsaicin
    • Other: Voluntary cough test
  • Experimental: Parkinson's disease
    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.
    Interventions:
    • Drug: Capsaicin
    • Other: Voluntary cough test
Publications * Smith JA, Aliverti A, Quaranta M, McGuinness K, Kelsall A, Earis J, Calverley PM. Chest wall dynamics during voluntary and induced cough in healthy volunteers. J Physiol. 2012 Feb 1;590(3):563-74. doi: 10.1113/jphysiol.2011.213157. Epub 2011 Dec 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 15, 2015)
44
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2014)
68
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02183519
Other Study ID Numbers  ICMJE IRB201400477
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karen W. Hegland, Ph.D. University of Florida
Study Director: Alexandra E. Brandimore, M.A. CCC/SLP University of Florida
PRS Account University of Florida
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP