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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Cough Parkinson's Disease Drug: Capsaicin Other: Voluntary cough test Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
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
Official Title: Respiratory Kinematics of Reflex and Voluntary Cough in Healthy Older Adults and Parkinson's Disease
Study Start Date : October 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02183519


Locations
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United States, Florida
Center for Movement Disorders and Neurorestoration
Gainesville, Florida, United States, 32611
Dauer Hall, University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Karen W. Hegland, Ph.D. University of Florida
Study Director: Alexandra E. Brandimore, M.A. CCC/SLP University of Florida

Publications:
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02183519    
Other Study ID Numbers: IRB201400477
First Posted: July 8, 2014    Key Record Dates
Results First Posted: March 24, 2017
Last Update Posted: March 24, 2017
Last Verified: February 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Cough
Reflex
Voluntary
Healthy older adults
Parkinson's disease
Respiratory kinematics
Cueing
Additional relevant MeSH terms:
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Cough
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs