Airway Protective Mechanisms in PD (R01)

NCT03321019 | Completed Results DMC FDA Drug

• 2 other identifiers: IRB201700959-N5R01HD091658-05
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

This study will collect data on various aspects of airway sensation and function, and determine how it relates to the development of swallowing and cough dysfunction in Parkinson's disease. Participants will be followed over a 3-year period, with once-per-year visits to collect the data.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (3)

• Respiratory Sensitivity

  Slope of perception of resistive load and load resistance: Magnitude estimation of respiratory load (6 - no difficulty inhaling - 20 maximum difficulty inhaling) is plotted on the y-axis and respiratory load (0, 5, 10, 25 \& 40 cm H2O loads) is plotted on the x-axis. The slope of the resulting regression line is the measure.

  3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit)

• Urge to Cough Sensitivity

  Urge to cough sensitivity slope: Slope of the line created by plotting the urge to cough (0 indicating none - 10 indicating maximal) on the y-axis and capsaicin concentration (increasing from 0, 25, 50, 100, 200 micromolar) on the x-axis.

  3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit)

• Penetration-aspiration Scale

  Rating of airway intrusion of bolus material during swallowing ranging from 1 (best, no airway invasion) to 8 (worst, silent aspiration).

  3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit)

Secondary Outcomes (2)

• Cough Peak Flow Rate

  3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit)

• Swallowing Timing

  3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit)

Study Arms (2)

Healthy controls

Men and women between the ages of 45 and 85 years without Parkinson's disease, or any history of neurologic disorder/disease, head or neck cancer, or chronic respiratory illness.

Drug: Capsaicin; Device: Resistive respiratory loads; Other: Event-related evoked potential using electroencephalography (EEG).; Procedure: Fluoroscopic swallow evaluation

Parkinson's disease

Men and women between the ages of 45 and 85 years with Parkinson's disease, and without any history of neurologic disorder/disease, head or neck cancer, or chronic respiratory illness.

Drug: Capsaicin; Device: Resistive respiratory loads; Other: Event-related evoked potential using electroencephalography (EEG).; Procedure: Fluoroscopic swallow evaluation

Interventions

Capsaicin DRUG

Participants will inhale aerosolized capsaicin with the goal of this inducing cough and an urge-to-cough.

Healthy controls; Parkinson's disease

Resistive respiratory loads DEVICE

Participants will breath through a mouthpiece. Every 3-5 breaths in, a respiratory load will be applied. Participants will be asked to rate the magnitude of the load.

Healthy controls; Parkinson's disease

Event-related evoked potential using electroencephalography (EEG). OTHER

The study team will use EEG time-locked to a respiratory occlusion to measure the brain's response to respiratory sensation.

Also known as: ERP, RREP

Healthy controls; Parkinson's disease

Fluoroscopic swallow evaluation PROCEDURE

Participants will swallow various consistencies of barium under fluoroscopy (moving-picture x-ray) in order to assess swallowing safety and efficiency.

Also known as: Modified barium swallow

Healthy controls; Parkinson's disease

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study includes both male and female participants. One study group (control group) will be adults between 45 and 85 years of age without Parkinson's disease. The other group will consist of adults between 45 and 85 years of age with Parkinson's disease diagnosed by a movement disorders trained neurologist, according to UK brain bank criteria.

You may qualify if:

• Between the ages of 45 and 85 years
• Diagnosis of PD, Hoehn and Yahr stages I - IV, by a fellowship trained neurologist arriving at the diagnosis of PD by applying strict UK brain bank criteria (PD participants only)

You may not qualify if:

• Neurological disorders other than PD (i.e., stroke, etc.)
• Difficulty complying due to neuropsychological dysfunction (i.e., severe depression)
• Allergy to capsaicin or hot peppers
• History of head or neck cancer
• History of smoking in the past 5 years
• Any neurological disorder including PD (Healthy control group only)

Sponsors & Collaborators

• University of Florida: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Florida Center for Movement Disorders and Neurorestoration

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Limitations and Caveats

This study spanned the time of the global COVID pandemic, so many of the participants lost to follow up, and limited ability to recruit, were a direct result of restrictions put in place between March 2020 and March 2021.

Results Point of Contact

• Title: Dr. Karen Hegland
• Organization: University of Florida

kwheeler@ufl.edu

3522948366

Study Officials

• Karen Hegland, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: October 25, 2017
• Study Start: December 12, 2017
• Primary Completion: July 29, 2023
• Study Completion: September 29, 2023
• Last Updated: October 10, 2024
• Results First Posted: October 10, 2024

Record last verified: 2024-10

Locations

US (1)