Cough According to Stimulus Type in PD

NCT ID: NCT02390089

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2019-02-13

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Healthy control

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.

Group Type: ACTIVE_COMPARATOR

Capsaicin vapor

Intervention Type: DRUG

Single-breath and continuous inhalation paradigm to induce cough.

Nebulizer

Intervention Type: DEVICE

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.

Parkinson's disease - no PA

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.

Group Type: EXPERIMENTAL

Capsaicin vapor

Intervention Type: DRUG

Single-breath and continuous inhalation paradigm to induce cough.

fog

Intervention Type: OTHER

Continuous inhalation of fog until a cough is produced, or up to 60 seconds (whichever is shortest)

Videofluoroscopic swallow evaluation

Intervention Type: RADIATION

Fluoroscopic evaluation of oropharyngeal swallowing function.

Nebulizer

Intervention Type: DEVICE

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.

Parkinson's disease - PA

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.

Group Type: EXPERIMENTAL

Capsaicin vapor

Intervention Type: DRUG

Single-breath and continuous inhalation paradigm to induce cough.

fog

Intervention Type: OTHER

Continuous inhalation of fog until a cough is produced, or up to 60 seconds (whichever is shortest)

Videofluoroscopic swallow evaluation

Intervention Type: RADIATION

Fluoroscopic evaluation of oropharyngeal swallowing function.

Nebulizer

Intervention Type: DEVICE

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.

Interventions

Capsaicin vapor

Single-breath and continuous inhalation paradigm to induce cough.

Intervention Type: DRUG

fog

Continuous inhalation of fog until a cough is produced, or up to 60 seconds (whichever is shortest)

Intervention Type: OTHER

Videofluoroscopic swallow evaluation

Fluoroscopic evaluation of oropharyngeal swallowing function.

Intervention Type: RADIATION

Nebulizer

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.

Intervention Type: DEVICE

Other Intervention Names

hot pepper vapor; aerosolized water; Swallow study; Modified barium swallow study

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen W Hegland, PHD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida Center for Movement Disorders and Neurorestoration

Gainesville, Florida, United States

Countries

United States

Other Identifiers

1R21DC014567-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB201401059-N

Identifier Type: -

Identifier Source: org_study_id