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Cough According to Stimulus Type in PD

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Capsaicin vapor
fog
Videofluoroscopic swallow evaluation
Nebulizer
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinson's Disease focused on measuring Dysphagia, Cough, Aspiration pneumonia

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Within age limits
  • For PD group: confirmed diagnosis of idiopathic parkinson's disease

Exclusion Criteria:

  • Uncontrolled hypertension
  • Difficulty complying due to neuropsychological dysfunction (i.e., severe depression)
  • Allergy to capsaicin or hot peppers
  • History of head or neck cancer
  • Neurological disorders other than PD (i.e., stroke, etc.)

    1. control participants only: any history of neurologic disorders including PD

  • History of smoking in the last 5 years
  • Breathing disorders or diseases

Sites / Locations

  • University of Florida Center for Movement Disorders and Neurorestoration

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Healthy control

Parkinson's disease - no PA

Parkinson's disease - PA

Arm Description

Healthy age-matched adult participants with no history of Parkinson's disease Participants in this group will receive capsaicin vapor cough provocation test. The vapor will be delivered using a small hand-held nebulizer.

People with Parkinson's disease without penetration or aspiration during swallowing; based on results of videofluoroscopic swallow evaluation. Participants in this group will receive capsaicin vapor and fog cough provocation test using a small, hand-held nebulizer.Participants in the group will also receive a fluoroscopic swallow evaluation.

People with Parkinson's disease with penetration or aspiration during swallowing;based on results of videofluoroscopic swallow evaluation.Participants in this group will receive capsaicin vapor and fog cough provocation test using a small, hand-held nebulizer. Participants in the group will also receive a fluoroscopic swallow evaluation.

Outcomes

Primary Outcome Measures

Urge-to-cough sensitivity
Slope of the line created by plotting urge-to-cough (scale of 1-11) with capsaicin concentration (5 doses of increasing intensity).
Positive/negative cough response
A positive response is 2 coughs produced to 2/3 trials of the stimulus

Secondary Outcome Measures

Latency
Time from stimulus presentation to cough produced.
Cough sensitivity threshold
the lowest concentration of capsaicin that elicits a perceived urge to cough of 1 (very slight) in at least 2/3 trials
Cough motor threshold
the lowest concentration of capsaicin that elicits at least 2 cough responses in 2/3 trials

Full Information

First Posted
February 19, 2015
Last Updated
February 13, 2019
Sponsor
University of Florida
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT02390089
Brief Title
Cough According to Stimulus Type in PD
Official Title
Airway Protection Deficits According to Stimulus Type in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
February 10, 2017 (Actual)
Study Completion Date
February 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Aspiration pneumonia (APn) occurs at a higher rate in patients with Parkinson's disease (PD) versus healthy adults. This is of particular public health concern given that death secondary to aspiration pneumonia and lung infection is a leading cause of death in persons with PD. Swallowing and cough function are affected in PD, putting people with PD at significant risk for uncompensated aspiration (aspiration without adequate cough response). One challenge in the management of airway protective deficits related to PD is the chronic and progressive nature of the disease, where swallowing dysfunction appears subtly in the form of microaspiration, reducing the perceived urgency of the swallowing disorder by both clinicians and patients. The long-term goal of this research is to advance the management of airway protection deficits in patients with neurodegenerative disease in order to decrease morbidity and mortality due to aspiration related lung infection. The objective here is to further specify deficits leading to uncompensated airway compromise in PD in order to advance the clinical management of these patients, leading to an immediate positive impact.
Detailed Description
The study will be completed in one visit, and take about an hour. All study procedures are done in the investigators quiet clinical research area at the Center for Movement Disorders and Neurorestoration (Room 7). If participants agree to be in this research study, after participants sign the informed consent form, the investigators will ask participants some questions related to participants health history. These questions include: Do participants have a history of any breathing disorders or diseases (asthma, emphysema/chronic obstructive pulmonary disease (COPD), etc), or severe chest injury? Do participants have any history of stroke, or any neurologic disease besides Parkinson's disease? Have participants smoked in the last 5 years? Have participants had any chest infections within the last 5 the weeks? Do participants have a history of head and neck cancer? Are participants allergic to capsaicin, hot peppers, Zostrix cream, or other medicines? The investigators will ask these questions to make sure participants do not have a history of any illnesses that would affect their ability to cough or that would make it unsafe for them to participate. If participants answer yes to any of these questions, they will not be able to continue in the study. Next, the investigators will begin to measure participants reflex cough. First, the investigators will attach a small microphone with a clip to participants shirt that will record participants cough responses. The investigators will have participants inhale a "hot pepper" vapor at five different concentrations. The hot pepper vapors will be separately delivered through a mouthpiece attached to a hand-held nebulizer (a device that makes vapors out of liquids). The investigators will deliver each type of vapor to participants 3 times each for a total of 15 presentations. After inhaling each vapor and coughing if participants need to, the investigators will ask participants to rate their urge to cough using a scale of 0-10, with 0 equaling no urge to cough, and 10 equaling the greatest urge to cough. If participants do not cough to any of the vapors, the investigators will present one final stronger dose. There will be a 2 minute break in between each presentation of the vapor, and water will be available at all times throughout the study. This will take approximately 40 minutes. Next, the investigators will continue to measure participants reflex cough using a slightly different test. The investigators will have participants inhale water vapor (fog) and a low concentration of hot pepper vapor. Both types of vapor will be in separate nebulizers, like the ones the investigators just used. For these vapors, participants will breathe in and out through the nebulizer's mouthpiece until participants cough, or for up to 1 minute. The investigators will try each one 3 times, for a total of 6 tries.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Dysphagia, Cough, Aspiration pneumonia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy control
Arm Type
Active Comparator
Arm Description
Healthy age-matched adult participants with no history of Parkinson's disease Participants in this group will receive capsaicin vapor cough provocation test. The vapor will be delivered using a small hand-held nebulizer.
Arm Title
Parkinson's disease - no PA
Arm Type
Experimental
Arm Description
People with Parkinson's disease without penetration or aspiration during swallowing; based on results of videofluoroscopic swallow evaluation. Participants in this group will receive capsaicin vapor and fog cough provocation test using a small, hand-held nebulizer.Participants in the group will also receive a fluoroscopic swallow evaluation.
Arm Title
Parkinson's disease - PA
Arm Type
Experimental
Arm Description
People with Parkinson's disease with penetration or aspiration during swallowing;based on results of videofluoroscopic swallow evaluation.Participants in this group will receive capsaicin vapor and fog cough provocation test using a small, hand-held nebulizer. Participants in the group will also receive a fluoroscopic swallow evaluation.
Intervention Type
Drug
Intervention Name(s)
Capsaicin vapor
Other Intervention Name(s)
hot pepper vapor
Intervention Description
Single-breath and continuous inhalation paradigm to induce cough.
Intervention Type
Other
Intervention Name(s)
fog
Other Intervention Name(s)
aerosolized water
Intervention Description
Continuous inhalation of fog until a cough is produced, or up to 60 seconds (whichever is shortest)
Intervention Type
Radiation
Intervention Name(s)
Videofluoroscopic swallow evaluation
Other Intervention Name(s)
Swallow study, Modified barium swallow study
Intervention Description
Fluoroscopic evaluation of oropharyngeal swallowing function.
Intervention Type
Device
Intervention Name(s)
Nebulizer
Intervention Description
A hand-held nebulizer will be used to aerosolize the capsaicin and water solutions. Participants will inhale through the device's mouthpiece, and cough if they need to.
Primary Outcome Measure Information:
Title
Urge-to-cough sensitivity
Description
Slope of the line created by plotting urge-to-cough (scale of 1-11) with capsaicin concentration (5 doses of increasing intensity).
Time Frame
30 minute
Title
Positive/negative cough response
Description
A positive response is 2 coughs produced to 2/3 trials of the stimulus
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Latency
Description
Time from stimulus presentation to cough produced.
Time Frame
10 minutes
Title
Cough sensitivity threshold
Description
the lowest concentration of capsaicin that elicits a perceived urge to cough of 1 (very slight) in at least 2/3 trials
Time Frame
30 minutes
Title
Cough motor threshold
Description
the lowest concentration of capsaicin that elicits at least 2 cough responses in 2/3 trials
Time Frame
30 minutes
Other Pre-specified Outcome Measures:
Title
Swallowing group
Description
The total number of participants with and without penetration or aspiration of material to the airway during swallow evaluation. Two groups will be identified, those with penetration or aspiration (PD-PA) and those without (PD).
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Within age limits For PD group: confirmed diagnosis of idiopathic parkinson's disease Exclusion Criteria: Uncontrolled hypertension Difficulty complying due to neuropsychological dysfunction (i.e., severe depression) Allergy to capsaicin or hot peppers History of head or neck cancer Neurological disorders other than PD (i.e., stroke, etc.) 1. control participants only: any history of neurologic disorders including PD History of smoking in the last 5 years Breathing disorders or diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen W Hegland, PHD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida Center for Movement Disorders and Neurorestoration
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States

12. IPD Sharing Statement

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Cough According to Stimulus Type in PD

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